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1. Clinical Efficacy of ONC201 in H3K27M-Mutant Diffuse Midline Gliomas Is Driven by Disruption of Integrated Metabolic and Epigenetic Pathways.

Author

Sweha, Stefan, Mota, Mateus, Pun, Matthew, Deogharkar, Akash, Chung, Chan, Tarapore, Rohinton, Ramage, Samuel, Chi, Andrew, Wen, Patrick, Arrillaga-Romany, Isabel, Batchelor, Tracy, Butowski, Nicholas, Sumrall, Ashley, Shonka, Nicole, Harrison, Rebecca, de Groot, John, Mehta, Minesh, Hall, Matthew, Daghistani, Doured, Cloughesy, Timothy, Ellingson, Benjamin, Beccaria, Kevin, Varlet, Pascale, Kim, Michelle, Umemura, Yoshie, Garton, Hugh, Franson, Andrea, Schwartz, Jonathan, Jain, Rajan, Kachman, Maureen, Baum, Heidi, Burant, Charles, Mottl, Sophie, Cartaxo, Rodrigo, John, Vishal, Messinger, Dana, Qin, Tingting, Peterson, Erik, Sajjakulnukit, Peter, Ravi, Karthik, Waugh, Alyssa, Walling, Dustin, Ding, Yujie, Xia, Ziyun, Schwendeman, Anna, Hawes, Debra, Yang, Fusheng, Judkins, Alexander, Wahl, Daniel, Lyssiotis, Costas, de la Nava, Daniel, Alonso, Marta, Eze, Augustine, Spitzer, Jasper, Schmidt, Susanne, Duchatel, Ryan, Dun, Matthew, Cain, Jason, Jiang, Li, Stopka, Sylwia, Baquer, Gerard, Regan, Michael, Filbin, Mariella, Agar, Nathalie, Zhao, Lili, Kumar-Sinha, Chandan, Mody, Rajen, Chinnaiyan, Arul, Kurokawa, Ryo, Pratt, Drew, Yadav, Viveka, Grill, Jacques, Kline, Cassie, Venneti, Sriram, Kawakibi, Abed, Ji, Sunjong, Resnick, Adam, Nazarian, Javad, Allen, Joshua, Odia, Yazmin, Gardner, Sharon, Koschmann, Carl, Mueller, Sabine, and Waszak, Sebastian

Subjects
Humans, Glioma, Brain Neoplasms, Histones, Treatment Outcome, Epigenesis, Genetic, Mutation
Abstract

UNLABELLED: Patients with H3K27M-mutant diffuse midline glioma (DMG) have no proven effective therapies. ONC201 has recently demonstrated efficacy in these patients, but the mechanism behind this finding remains unknown. We assessed clinical outcomes, tumor sequencing, and tissue/cerebrospinal fluid (CSF) correlate samples from patients treated in two completed multisite clinical studies. Patients treated with ONC201 following initial radiation but prior to recurrence demonstrated a median overall survival of 21.7 months, whereas those treated after recurrence had a median overall survival of 9.3 months. Radiographic response was associated with increased expression of key tricarboxylic acid cycle-related genes in baseline tumor sequencing. ONC201 treatment increased 2-hydroxyglutarate levels in cultured H3K27M-DMG cells and patient CSF samples. This corresponded with increases in repressive H3K27me3 in vitro and in human tumors accompanied by epigenetic downregulation of cell cycle regulation and neuroglial differentiation genes. Overall, ONC201 demonstrates efficacy in H3K27M-DMG by disrupting integrated metabolic and epigenetic pathways and reversing pathognomonic H3K27me3 reduction. SIGNIFICANCE: The clinical, radiographic, and molecular analyses included in this study demonstrate the efficacy of ONC201 in H3K27M-mutant DMG and support ONC201 as the first monotherapy to improve outcomes in H3K27M-mutant DMG beyond radiation. Mechanistically, ONC201 disrupts integrated metabolic and epigenetic pathways and reverses pathognomonic H3K27me3 reduction. This article is featured in Selected Articles from This Issue, p. 2293.

Published
2023

3. Pediatric and adult H3 K27M-mutant diffuse midline glioma treated with the selective DRD2 antagonist ONC201.

Author

Chi, Andrew, Tarapore, Rohinton, Hall, Matthew, Shonka, Nicole, Gardner, Sharon, Umemura, Yoshie, Sumrall, Ashley, Khatib, Ziad, Mueller, Sabine, Kline, Cassie, Zaky, Wafik, Khatua, Soumen, Weathers, Shiao-Pei, Odia, Yazmin, Niazi, Toba, Daghistani, Doured, Cherrick, Irene, Korones, David, Karajannis, Matthias, Kong, Xiao-Tang, Minturn, Jane, Waanders, Angela, Arillaga-Romany, Isabel, Batchelor, Tracy, Wen, Patrick, Merdinger, Krystal, Schalop, Lee, Stogniew, Martin, Allen, Joshua, Oster, Wolfgang, and Mehta, Minesh

Subjects
Adult, DRD2 antagonist, Diffuse intrinsic pontine, Diffuse midline, Glioma, H3 K27M, ONC201, Pediatric, Radiation, Adolescent, Adult, Antineoplastic Agents, Brain Neoplasms, Child, Child, Preschool, Female, Follow-Up Studies, Glioma, Heterocyclic Compounds, 4 or More Rings, Histones, Humans, Imidazoles, Male, Mutation, Prognosis, Pyridines, Pyrimidines, Receptors, Dopamine D2, Survival Rate, Young Adult
Abstract

BACKGROUND: H3 K27M-mutant diffuse midline glioma is a fatal malignancy with no proven medical therapies. The entity predominantly occurs in children and young adults. ONC201 is a small molecule selective antagonist of dopamine receptor D2/3 (DRD2/3) with an exceptional safety profile. Following up on a durable response in the first H3 K27M-mutant diffuse midline glioma patient who received ONC201 (NCT02525692), an expanded access program was initiated. METHODS: Patients with H3 K27M-mutant gliomas who received at least prior radiation were eligible. Patients with leptomeningeal spread were excluded. All patients received open-label ONC201 orally once every week. Safety, radiographic assessments, and overall survival were regularly assessed at least every 8 weeks by investigators. As of August 2018, a total of 18 patients with H3 K27M-mutant diffuse midline glioma or DIPG were enrolled to single patient expanded access ONC201 protocols. Among the 18 patients: seven adult (> 20 years old) and seven pediatric (< 20 years old) patients initiated ONC201 with recurrent disease and four pediatric patients initiated ONC201 following radiation, but prior to disease recurrence. FINDINGS: Among the 14 patients with recurrent disease prior to initiation of ONC201, median progression-free survival is 14 weeks and median overall survival is 17 weeks. Three adults among the 14 recurrent patients remain on treatment progression-free with a median follow up of 49.6 (range 41-76.1) weeks. Among the 4 pediatric patients who initiated adjuvant ONC201 following radiation, two DIPG patients remain progression-free for at least 53 and 81 weeks. Radiographic regressions, including a complete response, were reported by investigators in a subset of patients with thalamic and pontine gliomas, along with improvements in disease-associated neurological symptoms. INTERPRETATION: The clinical outcomes and radiographic responses in these patients provide the preliminary, and initial clinical proof-of-concept for targeting H3 K27M-mutant diffuse midline glioma with ONC201, regardless of age or location, providing rationale for robust clinical testing of the agent.

Published
2019

4. ACTION: A randomized phase 3 study of ONC201 (dordaviprone) in patients with newly diagnosed H3 K27M-mutant diffuse glioma

Author

Arrillaga-Romany, Isabel, primary, Lassman, Andrew, additional, McGovern, Susan L, additional, Mueller, Sabine, additional, Nabors, Burt, additional, van den Bent, Martin, additional, Vogelbaum, Michael, additional, Allen, Joshua E, additional, Melemed, Allen S, additional, Tarapore, Rohinton S, additional, Wen, Patrick Y, additional, and Cloughesy, Timothy, additional

Published
2024
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5. ONC201 (Dordaviprone) in Recurrent H3 K27M–Mutant Diffuse Midline Glioma

Author

Arrillaga-Romany, Isabel, primary, Gardner, Sharon L., additional, Odia, Yazmin, additional, Aguilera, Dolly, additional, Allen, Joshua E., additional, Batchelor, Tracy, additional, Butowski, Nicholas, additional, Chen, Clark, additional, Cloughesy, Timothy, additional, Cluster, Andrew, additional, de Groot, John, additional, Dixit, Karan S., additional, Graber, Jerome J., additional, Haggiagi, Aya M., additional, Harrison, Rebecca A., additional, Kheradpour, Albert, additional, Kilburn, Lindsay B., additional, Kurz, Sylvia C., additional, Lu, Guangrong, additional, MacDonald, Tobey J., additional, Mehta, Minesh, additional, Melemed, Allen S., additional, Nghiemphu, Phioanh Leia, additional, Ramage, Samuel C., additional, Shonka, Nicole, additional, Sumrall, Ashley, additional, Tarapore, Rohinton S., additional, Taylor, Lynne, additional, Umemura, Yoshie, additional, and Wen, Patrick Y., additional

Published
2024
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6. ACTION:a randomized phase 3 study of ONC201 (dordaviprone) in patients with newly diagnosed H3 K27M-mutant diffuse glioma

Author

Arrillaga-Romany, Isabel, Lassman, Andrew, McGovern, Susan L., Mueller, Sabine, Nabors, Burt, van den Bent, Martin, Vogelbaum, Michael A., Allen, Joshua E., Melemed, Allen S., Tarapore, Rohinton S., Wen, Patrick Y., Cloughesy, Timothy, Arrillaga-Romany, Isabel, Lassman, Andrew, McGovern, Susan L., Mueller, Sabine, Nabors, Burt, van den Bent, Martin, Vogelbaum, Michael A., Allen, Joshua E., Melemed, Allen S., Tarapore, Rohinton S., Wen, Patrick Y., and Cloughesy, Timothy

Abstract

BACKGROUND: H3 K27M-mutant diffuse glioma primarily affects children and young adults, is associated with a poor prognosis, and no effective systemic therapy is currently available. ONC201 (dordaviprone) has previously demonstrated efficacy in patients with recurrent disease. This phase 3 trial evaluates ONC201 in patients with newly diagnosed H3 K27M-mutant glioma.METHODS: ACTION (NCT05580562) is a randomized, double-blind, placebo-controlled, parallel-group, international phase 3 study of ONC201 in newly diagnosed H3 K27M-mutant diffuse glioma. Patients who have completed standard frontline radiotherapy are randomized 1:1:1 to receive placebo, once-weekly dordaviprone, or twice-weekly dordaviprone on 2 consecutive days. Primary efficacy endpoints are overall survival (OS) and progression-free survival (PFS); PFS is assessed by response assessment in neuro-oncology high-grade glioma criteria (RANO-HGG) by blind independent central review. Secondary objectives include safety, additional efficacy endpoints, clinical benefit, and quality of life. Eligible patients have histologically confirmed H3 K27M-mutant diffuse glioma, a Karnofsky/Lansky performance status ≥70, and completed first-line radiotherapy. Eligibility is not restricted by age; however, patients must be ≥10 kg at time of randomization. Patients with a primary spinal tumor, diffuse intrinsic pontine glioma, leptomeningeal disease, or cerebrospinal fluid dissemination are not eligible. ACTION is currently enrolling in multiple international sites.

Published
2024

7. ONC201 and imipridones: Anti-cancer compounds with clinical efficacy

Author

Prabhu, Varun Vijay, Morrow, Sara, Rahman Kawakibi, Abed, Zhou, Lanlan, Ralff, Marie, Ray, Jocelyn, Jhaveri, Aakash, Ferrarini, Isacco, Lee, Young, Parker, Cassandra, Zhang, Yiqun, Borsuk, Robyn, Chang, Wen-I, Honeyman, Joshua N., Tavora, Fabio, Carneiro, Benedito, Raufi, Alexander, Huntington, Kelsey, Carlsen, Lindsey, Louie, Anna, Safran, Howard, Seyhan, Attila A., Tarapore, Rohinton S., Schalop, Lee, Stogniew, Martin, Allen, Joshua E., Oster, Wolfgang, and El-Deiry, Wafik S.

Published
2020
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9. Table S4 from Clinical Efficacy of ONC201 in H3K27M-Mutant Diffuse Midline Gliomas Is Driven by Disruption of Integrated Metabolic and Epigenetic Pathways

Author

Venneti, Sriram, primary, Kawakibi, Abed Rahman, primary, Ji, Sunjong, primary, Waszak, Sebastian M., primary, Sweha, Stefan R., primary, Mota, Mateus, primary, Pun, Matthew, primary, Deogharkar, Akash, primary, Chung, Chan, primary, Tarapore, Rohinton S., primary, Ramage, Samuel, primary, Chi, Andrew, primary, Wen, Patrick Y., primary, Arrillaga-Romany, Isabel, primary, Batchelor, Tracy T., primary, Butowski, Nicholas A., primary, Sumrall, Ashley, primary, Shonka, Nicole, primary, Harrison, Rebecca A., primary, de Groot, John, primary, Mehta, Minesh, primary, Hall, Matthew D., primary, Daghistani, Doured, primary, Cloughesy, Timothy F., primary, Ellingson, Benjamin M., primary, Beccaria, Kevin, primary, Varlet, Pascale, primary, Kim, Michelle M., primary, Umemura, Yoshie, primary, Garton, Hugh, primary, Franson, Andrea, primary, Schwartz, Jonathan, primary, Jain, Rajan, primary, Kachman, Maureen, primary, Baum, Heidi, primary, Burant, Charles F., primary, Mottl, Sophie L., primary, Cartaxo, Rodrigo T., primary, John, Vishal, primary, Messinger, Dana, primary, Qin, Tingting, primary, Peterson, Erik, primary, Sajjakulnukit, Peter, primary, Ravi, Karthik, primary, Waugh, Alyssa, primary, Walling, Dustin, primary, Ding, Yujie, primary, Xia, Ziyun, primary, Schwendeman, Anna, primary, Hawes, Debra, primary, Yang, Fusheng, primary, Judkins, Alexander R., primary, Wahl, Daniel, primary, Lyssiotis, Costas A., primary, de la Nava, Daniel, primary, Alonso, Marta M., primary, Eze, Augustine, primary, Spitzer, Jasper, primary, Schmidt, Susanne V., primary, Duchatel, Ryan J., primary, Dun, Matthew D., primary, Cain, Jason E., primary, Jiang, Li, primary, Stopka, Sylwia A., primary, Baquer, Gerard, primary, Regan, Michael S., primary, Filbin, Mariella G., primary, Agar, Nathalie Y.R., primary, Zhao, Lili, primary, Kumar-Sinha, Chandan, primary, Mody, Rajen, primary, Chinnaiyan, Arul, primary, Kurokawa, Ryo, primary, Pratt, Drew, primary, Yadav, Viveka N., primary, Grill, Jacques, primary, Kline, Cassie, primary, Mueller, Sabine, primary, Resnick, Adam, primary, Nazarian, Javad, primary, Allen, Joshua E., primary, Odia, Yazmin, primary, Gardner, Sharon L., primary, and Koschmann, Carl, primary

Published
2023
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10. Supplementary Figures 1-15 from Clinical Efficacy of ONC201 in H3K27M-Mutant Diffuse Midline Gliomas Is Driven by Disruption of Integrated Metabolic and Epigenetic Pathways

Author

Venneti, Sriram, primary, Kawakibi, Abed Rahman, primary, Ji, Sunjong, primary, Waszak, Sebastian M., primary, Sweha, Stefan R., primary, Mota, Mateus, primary, Pun, Matthew, primary, Deogharkar, Akash, primary, Chung, Chan, primary, Tarapore, Rohinton S., primary, Ramage, Samuel, primary, Chi, Andrew, primary, Wen, Patrick Y., primary, Arrillaga-Romany, Isabel, primary, Batchelor, Tracy T., primary, Butowski, Nicholas A., primary, Sumrall, Ashley, primary, Shonka, Nicole, primary, Harrison, Rebecca A., primary, de Groot, John, primary, Mehta, Minesh, primary, Hall, Matthew D., primary, Daghistani, Doured, primary, Cloughesy, Timothy F., primary, Ellingson, Benjamin M., primary, Beccaria, Kevin, primary, Varlet, Pascale, primary, Kim, Michelle M., primary, Umemura, Yoshie, primary, Garton, Hugh, primary, Franson, Andrea, primary, Schwartz, Jonathan, primary, Jain, Rajan, primary, Kachman, Maureen, primary, Baum, Heidi, primary, Burant, Charles F., primary, Mottl, Sophie L., primary, Cartaxo, Rodrigo T., primary, John, Vishal, primary, Messinger, Dana, primary, Qin, Tingting, primary, Peterson, Erik, primary, Sajjakulnukit, Peter, primary, Ravi, Karthik, primary, Waugh, Alyssa, primary, Walling, Dustin, primary, Ding, Yujie, primary, Xia, Ziyun, primary, Schwendeman, Anna, primary, Hawes, Debra, primary, Yang, Fusheng, primary, Judkins, Alexander R., primary, Wahl, Daniel, primary, Lyssiotis, Costas A., primary, de la Nava, Daniel, primary, Alonso, Marta M., primary, Eze, Augustine, primary, Spitzer, Jasper, primary, Schmidt, Susanne V., primary, Duchatel, Ryan J., primary, Dun, Matthew D., primary, Cain, Jason E., primary, Jiang, Li, primary, Stopka, Sylwia A., primary, Baquer, Gerard, primary, Regan, Michael S., primary, Filbin, Mariella G., primary, Agar, Nathalie Y.R., primary, Zhao, Lili, primary, Kumar-Sinha, Chandan, primary, Mody, Rajen, primary, Chinnaiyan, Arul, primary, Kurokawa, Ryo, primary, Pratt, Drew, primary, Yadav, Viveka N., primary, Grill, Jacques, primary, Kline, Cassie, primary, Mueller, Sabine, primary, Resnick, Adam, primary, Nazarian, Javad, primary, Allen, Joshua E., primary, Odia, Yazmin, primary, Gardner, Sharon L., primary, and Koschmann, Carl, primary

Published
2023
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11. Supplementary Data S2 from Clinical Efficacy of ONC201 in H3K27M-Mutant Diffuse Midline Gliomas Is Driven by Disruption of Integrated Metabolic and Epigenetic Pathways

Author

Venneti, Sriram, primary, Kawakibi, Abed Rahman, primary, Ji, Sunjong, primary, Waszak, Sebastian M., primary, Sweha, Stefan R., primary, Mota, Mateus, primary, Pun, Matthew, primary, Deogharkar, Akash, primary, Chung, Chan, primary, Tarapore, Rohinton S., primary, Ramage, Samuel, primary, Chi, Andrew, primary, Wen, Patrick Y., primary, Arrillaga-Romany, Isabel, primary, Batchelor, Tracy T., primary, Butowski, Nicholas A., primary, Sumrall, Ashley, primary, Shonka, Nicole, primary, Harrison, Rebecca A., primary, de Groot, John, primary, Mehta, Minesh, primary, Hall, Matthew D., primary, Daghistani, Doured, primary, Cloughesy, Timothy F., primary, Ellingson, Benjamin M., primary, Beccaria, Kevin, primary, Varlet, Pascale, primary, Kim, Michelle M., primary, Umemura, Yoshie, primary, Garton, Hugh, primary, Franson, Andrea, primary, Schwartz, Jonathan, primary, Jain, Rajan, primary, Kachman, Maureen, primary, Baum, Heidi, primary, Burant, Charles F., primary, Mottl, Sophie L., primary, Cartaxo, Rodrigo T., primary, John, Vishal, primary, Messinger, Dana, primary, Qin, Tingting, primary, Peterson, Erik, primary, Sajjakulnukit, Peter, primary, Ravi, Karthik, primary, Waugh, Alyssa, primary, Walling, Dustin, primary, Ding, Yujie, primary, Xia, Ziyun, primary, Schwendeman, Anna, primary, Hawes, Debra, primary, Yang, Fusheng, primary, Judkins, Alexander R., primary, Wahl, Daniel, primary, Lyssiotis, Costas A., primary, de la Nava, Daniel, primary, Alonso, Marta M., primary, Eze, Augustine, primary, Spitzer, Jasper, primary, Schmidt, Susanne V., primary, Duchatel, Ryan J., primary, Dun, Matthew D., primary, Cain, Jason E., primary, Jiang, Li, primary, Stopka, Sylwia A., primary, Baquer, Gerard, primary, Regan, Michael S., primary, Filbin, Mariella G., primary, Agar, Nathalie Y.R., primary, Zhao, Lili, primary, Kumar-Sinha, Chandan, primary, Mody, Rajen, primary, Chinnaiyan, Arul, primary, Kurokawa, Ryo, primary, Pratt, Drew, primary, Yadav, Viveka N., primary, Grill, Jacques, primary, Kline, Cassie, primary, Mueller, Sabine, primary, Resnick, Adam, primary, Nazarian, Javad, primary, Allen, Joshua E., primary, Odia, Yazmin, primary, Gardner, Sharon L., primary, and Koschmann, Carl, primary

Published
2023
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12. TMET-02. CLINICAL EFFICACY OF ONC201 IN H3K27M-MUTANT DIFFUSE MIDLINE GLIOMAS IS DRIVEN BY DISRUPTION OF INTEGRATED METABOLIC AND EPIGENETIC PATHWAYS

Author

Venneti, Sriram, primary, Kawakibi, Abed Rahman, additional, Ji, Sunjong, additional, Waszak, Sebastian, additional, Sweha, Stefan, additional, Mota, Mateus, additional, Pun, Matthew, additional, Deogharkar, Akash, additional, Chung, Chan, additional, Tarapore, Rohinton, additional, Ramage, Samuel, additional, Wen, Patrick, additional, Arrillaga-Romany, Isabel, additional, Garton, Hugh, additional, Franson, Andrea, additional, Schwartz, Jonathan, additional, Jain, Rajan, additional, Mottl, Sophie, additional, Cartaxo, Rodrigo, additional, John, Vishal, additional, Messinger, Dana, additional, Qin, Tingting, additional, Peterson, Erik, additional, Sajjakulnukit, Peter, additional, Judkins, Alexander, additional, Wahl, Daniel, additional, Lyssiotis, Costas, additional, de la Nava, Daniel, additional, Alonso, Martha, additional, Duchatel, Ryan, additional, Dun, Matthew, additional, Cain, Jason, additional, Jiang, Li, additional, Filbin, Mariella, additional, Zhao, Lili, additional, Kumar-Sinha, Chandan, additional, Mody, Rajen, additional, Chinnaiyan, Arul, additional, Kurokawa, Ryo, additional, Pratt, Drew, additional, Yadav, Viveka, additional, Grill, Jacques, additional, Kline, Cassie, additional, Mueller, Sabine, additional, Resnick, Adam, additional, Nazarian, Javad, additional, Allen, Joshua, additional, Odia, Yazmin, additional, Gardner, Sharon, additional, and Koschmann, Carl, additional

Published
2023
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13. Data from Clinical Efficacy of ONC201 in H3K27M-Mutant Diffuse Midline Gliomas Is Driven by Disruption of Integrated Metabolic and Epigenetic Pathways

Author

Venneti, Sriram, primary, Kawakibi, Abed Rahman, primary, Ji, Sunjong, primary, Waszak, Sebastian M., primary, Sweha, Stefan R., primary, Mota, Mateus, primary, Pun, Matthew, primary, Deogharkar, Akash, primary, Chung, Chan, primary, Tarapore, Rohinton S., primary, Ramage, Samuel, primary, Chi, Andrew, primary, Wen, Patrick Y., primary, Arrillaga-Romany, Isabel, primary, Batchelor, Tracy T., primary, Butowski, Nicholas A., primary, Sumrall, Ashley, primary, Shonka, Nicole, primary, Harrison, Rebecca A., primary, de Groot, John, primary, Mehta, Minesh, primary, Hall, Matthew D., primary, Daghistani, Doured, primary, Cloughesy, Timothy F., primary, Ellingson, Benjamin M., primary, Beccaria, Kevin, primary, Varlet, Pascale, primary, Kim, Michelle M., primary, Umemura, Yoshie, primary, Garton, Hugh, primary, Franson, Andrea, primary, Schwartz, Jonathan, primary, Jain, Rajan, primary, Kachman, Maureen, primary, Baum, Heidi, primary, Burant, Charles F., primary, Mottl, Sophie L., primary, Cartaxo, Rodrigo T., primary, John, Vishal, primary, Messinger, Dana, primary, Qin, Tingting, primary, Peterson, Erik, primary, Sajjakulnukit, Peter, primary, Ravi, Karthik, primary, Waugh, Alyssa, primary, Walling, Dustin, primary, Ding, Yujie, primary, Xia, Ziyun, primary, Schwendeman, Anna, primary, Hawes, Debra, primary, Yang, Fusheng, primary, Judkins, Alexander R., primary, Wahl, Daniel, primary, Lyssiotis, Costas A., primary, de la Nava, Daniel, primary, Alonso, Marta M., primary, Eze, Augustine, primary, Spitzer, Jasper, primary, Schmidt, Susanne V., primary, Duchatel, Ryan J., primary, Dun, Matthew D., primary, Cain, Jason E., primary, Jiang, Li, primary, Stopka, Sylwia A., primary, Baquer, Gerard, primary, Regan, Michael S., primary, Filbin, Mariella G., primary, Agar, Nathalie Y.R., primary, Zhao, Lili, primary, Kumar-Sinha, Chandan, primary, Mody, Rajen, primary, Chinnaiyan, Arul, primary, Kurokawa, Ryo, primary, Pratt, Drew, primary, Yadav, Viveka N., primary, Grill, Jacques, primary, Kline, Cassie, primary, Mueller, Sabine, primary, Resnick, Adam, primary, Nazarian, Javad, primary, Allen, Joshua E., primary, Odia, Yazmin, primary, Gardner, Sharon L., primary, and Koschmann, Carl, primary

Published
2023
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14. Osteoblast Lineage Cells Play an Essential Role in Periodontal Bone Loss Through Activation of Nuclear Factor-Kappa B.

Author

Pacios, Sandra, Xiao, Wenmei, Mattos, Marcelo, Lim, Jason, Tarapore, Rohinton S, Alsadun, Sarah, Yu, Bo, Wang, Cun-Yu, and Graves, Dana T

Subjects
Osteoclasts, Osteoblasts, Animals, Mice, Transgenic, Mice, Alveolar Bone Loss, Periodontitis, Disease Models, Animal, Osteocalcin, NF-kappa B, Radiography, Protein Transport, Cell Lineage, Osteogenesis, Bone Density, Female, Male, RANK Ligand, Biomarkers, Dental/Oral and Craniofacial Disease, Infectious Diseases, Aging, 2.1 Biological and endogenous factors, 1.1 Normal biological development and functioning, Musculoskeletal, Transgenic, Disease Models, Animal, Biochemistry and Cell Biology, Other Physical Sciences
Abstract

Bacterial pathogens stimulate periodontitis, the most common osteolytic disease in humans and the most common cause of tooth loss in adults. Previous studies identified leukocytes and their products as key factors in this process. We demonstrate for the first time that osteoblast lineage cells play a critical role in periodontal disease. Oral infection stimulated nuclear localization of NF-κB in osteoblasts and osteocytes in the periodontium of wild type but not transgenic mice that expressed a lineage specific dominant negative mutant of IKK (IKK-DN) in osteoblast lineage cells. Wild-type mice were also susceptible to bacteria induced periodontal bone loss but transgenic mice were not. The lack of bone loss in the experimental group was linked to reduced RANKL expression by osteoblast lineage cells that led to diminished osteoclast mediated bone resorption and greater coupled new bone formation. The results demonstrate that osteoblast lineage cells are key contributors to periodontal bone loss through an NF-κB mediated mechanism.

Published
2015

17. Safety and pharmacokinetics of ONC201 (dordaviprone) administered two consecutive days per week in pediatric patients with H3 K27M-mutant glioma.

Author

Odia, Yazmin, Koschmann, Carl, Vitanza, Nicholas A, Blank, Peter de, Aguilera, Dolly, Allen, Jeffrey, Daghistani, Doured, Hall, Matthew, Khatib, Ziad, Kline, Cassie, MacDonald, Tobey, Mueller, Sabine, Faison, Shamia L, Allen, Joshua E, Naderer, Odin J, Ramage, Samuel C, Tarapore, Rohinton S, McGovern, Susan Lynne, Khatua, Soumen, and Zaky, Wafik

Published
2024
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18. Clinical Efficacy of ONC201 in H3K27M-Mutant Diffuse Midline Gliomas Is Driven by Disruption of Integrated Metabolic and Epigenetic Pathways

Author

Venneti, Sriram, primary, Kawakibi, Abed Rahman, additional, Ji, Sunjong, additional, Waszak, Sebastian M., additional, Sweha, Stefan R., additional, Mota, Mateus, additional, Pun, Matthew, additional, Deogharkar, Akash, additional, Chung, Chan, additional, Tarapore, Rohinton S., additional, Ramage, Samuel, additional, Chi, Andrew, additional, Wen, Patrick Y., additional, Arrillaga-Romany, Isabel, additional, Batchelor, Tracy T., additional, Butowski, Nicholas A., additional, Sumrall, Ashley, additional, Shonka, Nicole, additional, Harrison, Rebecca A., additional, de Groot, John, additional, Mehta, Minesh, additional, Hall, Matthew D., additional, Daghistani, Doured, additional, Cloughesy, Timothy F., additional, Ellingson, Benjamin M., additional, Beccaria, Kevin, additional, Varlet, Pascale, additional, Kim, Michelle M., additional, Umemura, Yoshie, additional, Garton, Hugh, additional, Franson, Andrea, additional, Schwartz, Jonathan, additional, Jain, Rajan, additional, Kachman, Maureen, additional, Baum, Heidi, additional, Burant, Charles F., additional, Mottl, Sophie L., additional, Cartaxo, Rodrigo T., additional, John, Vishal, additional, Messinger, Dana, additional, Qin, Tingting, additional, Peterson, Erik, additional, Sajjakulnukit, Peter, additional, Ravi, Karthik, additional, Waugh, Alyssa, additional, Walling, Dustin, additional, Ding, Yujie, additional, Xia, Ziyun, additional, Schwendeman, Anna, additional, Hawes, Debra, additional, Yang, Fusheng, additional, Judkins, Alexander R., additional, Wahl, Daniel, additional, Lyssiotis, Costas A., additional, de la Nava, Daniel, additional, Alonso, Marta M., additional, Eze, Augustine, additional, Spitzer, Jasper, additional, Schmidt, Susanne V., additional, Duchatel, Ryan J., additional, Dun, Matthew D., additional, Cain, Jason E., additional, Jiang, Li, additional, Stopka, Sylwia A., additional, Baquer, Gerard, additional, Regan, Michael S., additional, Filbin, Mariella G., additional, Agar, Nathalie Y.R., additional, Zhao, Lili, additional, Kumar-Sinha, Chandan, additional, Mody, Rajen, additional, Chinnaiyan, Arul, additional, Kurokawa, Ryo, additional, Pratt, Drew, additional, Yadav, Viveka N., additional, Grill, Jacques, additional, Kline, Cassie, additional, Mueller, Sabine, additional, Resnick, Adam, additional, Nazarian, Javad, additional, Allen, Joshua E., additional, Odia, Yazmin, additional, Gardner, Sharon L., additional, and Koschmann, Carl, additional

Published
2023
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19. TIPS-08 ACTION: A RANDOMIZED PHASE 3 STUDY OF DORDAVIPRONE (ONC201) IN PATIENTS WITH NEWLY DIAGNOSED H3 K27M-MUTANT DIFFUSE GLIOMA

Author

Arrillaga-Romany, Isabel, primary, Lassman, Andrew, additional, McGovern, Susan, additional, Mueller, Sabine, additional, Nabors, Louis Burt, additional, van den Bent, Martin, additional, Vogelbaum, Michael, additional, Allen, Joshua E, additional, Melemed, Allen S, additional, Tarapore, Rohinton, additional, Wen, Patrick, additional, and Cloughsey, Timothy, additional

Published
2023
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20. Abstract CT060: ACTION: A randomized phase 3 study of dordaviprone (ONC201) in patients with newly diagnosed H3 K27M-mutant diffuse glioma

Author

Arrillaga-Romany, Isabel, primary, Lassman, Andrew, additional, McGovern, Susan L., additional, Mueller, Sabine, additional, Nabors, Louis B., additional, van den Bent, Martin, additional, Vogelbaum, Michael, additional, Allen, Joshua E., additional, Melemed, Allen S., additional, Tarapore, Rohinton S., additional, Yang, Dewen, additional, Wen, Patrick, additional, and Cloughsey, Timothy, additional

Published
2023
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21. Figure S1 from Dopamine Receptor D5 is a Modulator of Tumor Response to Dopamine Receptor D2 Antagonism

Author

Prabhu, Varun V., primary, Madhukar, Neel S., primary, Gilvary, Coryandar, primary, Kline, C. Leah B., primary, Oster, Sophie, primary, El-Deiry, Wafik S., primary, Elemento, Olivier, primary, Doherty, Faye, primary, VanEngelenburg, Alexander, primary, Durrant, Jessica, primary, Tarapore, Rohinton S., primary, Deacon, Sean, primary, Charter, Neil, primary, Jung, Jinkyu, primary, Park, Deric M., primary, Gilbert, Mark R., primary, Rusert, Jessica, primary, Wechsler-Reya, Robert, primary, Arrillaga-Romany, Isabel, primary, Batchelor, Tracy T., primary, Wen, Patrick Y., primary, Oster, Wolfgang, primary, and Allen, Joshua E., primary

Published
2023
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22. Data from Dopamine Receptor D5 is a Modulator of Tumor Response to Dopamine Receptor D2 Antagonism

Author

Prabhu, Varun V., primary, Madhukar, Neel S., primary, Gilvary, Coryandar, primary, Kline, C. Leah B., primary, Oster, Sophie, primary, El-Deiry, Wafik S., primary, Elemento, Olivier, primary, Doherty, Faye, primary, VanEngelenburg, Alexander, primary, Durrant, Jessica, primary, Tarapore, Rohinton S., primary, Deacon, Sean, primary, Charter, Neil, primary, Jung, Jinkyu, primary, Park, Deric M., primary, Gilbert, Mark R., primary, Rusert, Jessica, primary, Wechsler-Reya, Robert, primary, Arrillaga-Romany, Isabel, primary, Batchelor, Tracy T., primary, Wen, Patrick Y., primary, Oster, Wolfgang, primary, and Allen, Joshua E., primary

Published
2023
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23. Table S1 from Dopamine Receptor D5 is a Modulator of Tumor Response to Dopamine Receptor D2 Antagonism

Author

Prabhu, Varun V., primary, Madhukar, Neel S., primary, Gilvary, Coryandar, primary, Kline, C. Leah B., primary, Oster, Sophie, primary, El-Deiry, Wafik S., primary, Elemento, Olivier, primary, Doherty, Faye, primary, VanEngelenburg, Alexander, primary, Durrant, Jessica, primary, Tarapore, Rohinton S., primary, Deacon, Sean, primary, Charter, Neil, primary, Jung, Jinkyu, primary, Park, Deric M., primary, Gilbert, Mark R., primary, Rusert, Jessica, primary, Wechsler-Reya, Robert, primary, Arrillaga-Romany, Isabel, primary, Batchelor, Tracy T., primary, Wen, Patrick Y., primary, Oster, Wolfgang, primary, and Allen, Joshua E., primary

Published
2023
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24. Supplementary Legends from Dopamine Receptor D5 is a Modulator of Tumor Response to Dopamine Receptor D2 Antagonism

Author

Prabhu, Varun V., primary, Madhukar, Neel S., primary, Gilvary, Coryandar, primary, Kline, C. Leah B., primary, Oster, Sophie, primary, El-Deiry, Wafik S., primary, Elemento, Olivier, primary, Doherty, Faye, primary, VanEngelenburg, Alexander, primary, Durrant, Jessica, primary, Tarapore, Rohinton S., primary, Deacon, Sean, primary, Charter, Neil, primary, Jung, Jinkyu, primary, Park, Deric M., primary, Gilbert, Mark R., primary, Rusert, Jessica, primary, Wechsler-Reya, Robert, primary, Arrillaga-Romany, Isabel, primary, Batchelor, Tracy T., primary, Wen, Patrick Y., primary, Oster, Wolfgang, primary, and Allen, Joshua E., primary

Published
2023
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25. Clinical Efficacy of ONC201 in H3K27M-Mutant Diffuse Midline Gliomas Is Driven by Disruption of Integrated Metabolic and Epigenetic Pathways

Author

Venneti, Sriram; https://orcid.org/0000-0001-9764-0423, Kawakibi, Abed Rahman; https://orcid.org/0000-0001-6347-8974, Ji, Sunjong; https://orcid.org/0000-0002-6516-2380, Waszak, Sebastian M; https://orcid.org/0000-0003-3042-9521, Sweha, Stefan R; https://orcid.org/0000-0002-1807-6770, Mota, Mateus; https://orcid.org/0009-0006-3126-8212, Pun, Matthew; https://orcid.org/0000-0002-4766-4301, Deogharkar, Akash; https://orcid.org/0009-0003-8980-0484, Chung, Chan; https://orcid.org/0000-0003-0510-8996, Tarapore, Rohinton S; https://orcid.org/0000-0002-8070-5646, Ramage, Samuel; https://orcid.org/0000-0002-0098-114X, Chi, Andrew; https://orcid.org/0000-0002-6642-1620, Wen, Patrick Y; https://orcid.org/0000-0002-0774-7700, Arrillaga-Romany, Isabel; https://orcid.org/0000-0001-5951-1225, Batchelor, Tracy T; https://orcid.org/0000-0001-7568-6607, Butowski, Nicholas A; https://orcid.org/0000-0001-5162-2406, Sumrall, Ashley; https://orcid.org/0000-0002-2863-203X, Shonka, Nicole; https://orcid.org/0000-0002-8182-3409, Harrison, Rebecca A; https://orcid.org/0000-0002-5689-8492, de Groot, John; https://orcid.org/0000-0003-1454-6461, Mehta, Minesh; https://orcid.org/0000-0002-4812-5713, Hall, Matthew D; https://orcid.org/0000-0001-8768-3577, Daghistani, Doured; https://orcid.org/0009-0007-2706-1611, Cloughesy, Timothy F; https://orcid.org/0000-0002-8656-7483, Ellingson, Benjamin M; https://orcid.org/0000-0002-2764-6640, Beccaria, Kevin; https://orcid.org/0000-0002-3405-1944, Varlet, Pascale; https://orcid.org/0000-0002-8164-1517, Kim, Michelle M; https://orcid.org/0000-0001-7566-6411, Mueller, Sabine; https://orcid.org/0000-0002-3452-5150, Nazarian, Javad; https://orcid.org/0000-0002-1951-9828, et al, Venneti, Sriram; https://orcid.org/0000-0001-9764-0423, Kawakibi, Abed Rahman; https://orcid.org/0000-0001-6347-8974, Ji, Sunjong; https://orcid.org/0000-0002-6516-2380, Waszak, Sebastian M; https://orcid.org/0000-0003-3042-9521, Sweha, Stefan R; https://orcid.org/0000-0002-1807-6770, Mota, Mateus; https://orcid.org/0009-0006-3126-8212, Pun, Matthew; https://orcid.org/0000-0002-4766-4301, Deogharkar, Akash; https://orcid.org/0009-0003-8980-0484, Chung, Chan; https://orcid.org/0000-0003-0510-8996, Tarapore, Rohinton S; https://orcid.org/0000-0002-8070-5646, Ramage, Samuel; https://orcid.org/0000-0002-0098-114X, Chi, Andrew; https://orcid.org/0000-0002-6642-1620, Wen, Patrick Y; https://orcid.org/0000-0002-0774-7700, Arrillaga-Romany, Isabel; https://orcid.org/0000-0001-5951-1225, Batchelor, Tracy T; https://orcid.org/0000-0001-7568-6607, Butowski, Nicholas A; https://orcid.org/0000-0001-5162-2406, Sumrall, Ashley; https://orcid.org/0000-0002-2863-203X, Shonka, Nicole; https://orcid.org/0000-0002-8182-3409, Harrison, Rebecca A; https://orcid.org/0000-0002-5689-8492, de Groot, John; https://orcid.org/0000-0003-1454-6461, Mehta, Minesh; https://orcid.org/0000-0002-4812-5713, Hall, Matthew D; https://orcid.org/0000-0001-8768-3577, Daghistani, Doured; https://orcid.org/0009-0007-2706-1611, Cloughesy, Timothy F; https://orcid.org/0000-0002-8656-7483, Ellingson, Benjamin M; https://orcid.org/0000-0002-2764-6640, Beccaria, Kevin; https://orcid.org/0000-0002-3405-1944, Varlet, Pascale; https://orcid.org/0000-0002-8164-1517, Kim, Michelle M; https://orcid.org/0000-0001-7566-6411, Mueller, Sabine; https://orcid.org/0000-0002-3452-5150, Nazarian, Javad; https://orcid.org/0000-0002-1951-9828, and et al

Abstract

UNLABELLED Patients with H3K27M-mutant diffuse midline glioma (DMG) have no proven effective therapies. ONC201 has recently demonstrated efficacy in these patients, but the mechanism behind this finding remains unknown. We assessed clinical outcomes, tumor sequencing, and tissue/cerebrospinal fluid (CSF) correlate samples from patients treated in two completed multisite clinical studies. Patients treated with ONC201 following initial radiation but prior to recurrence demonstrated a median overall survival of 21.7 months, whereas those treated after recurrence had a median overall survival of 9.3 months. Radiographic response was associated with increased expression of key tricarboxylic acid cycle-related genes in baseline tumor sequencing. ONC201 treatment increased 2-hydroxyglutarate levels in cultured H3K27M-DMG cells and patient CSF samples. This corresponded with increases in repressive H3K27me3 in vitro and in human tumors accompanied by epigenetic downregulation of cell cycle regulation and neuroglial differentiation genes. Overall, ONC201 demonstrates efficacy in H3K27M-DMG by disrupting integrated metabolic and epigenetic pathways and reversing pathognomonic H3K27me3 reduction. SIGNIFICANCE The clinical, radiographic, and molecular analyses included in this study demonstrate the efficacy of ONC201 in H3K27M-mutant DMG and support ONC201 as the first monotherapy to improve outcomes in H3K27M-mutant DMG beyond radiation. Mechanistically, ONC201 disrupts integrated metabolic and epigenetic pathways and reverses pathognomonic H3K27me3 reduction. This article is featured in Selected Articles from This Issue, p. 2293.

Published
2023

26. Safety and enhanced immunostimulatory activity of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration

Author

Stein, Mark N., Malhotra, Jyoti, Tarapore, Rohinton S., Malhotra, Usha, Silk, Ann W., Chan, Nancy, Rodriguez, Lorna, Aisner, Joseph, Aiken, Robert D., Mayer, Tina, Haffty, Bruce G., Newman, Jenna H., Aspromonte, Salvatore M., Bommareddy, Praveen K., Estupinian, Ricardo, Chesson, Charles B., Sadimin, Evita T., Li, Shengguo, Medina, Daniel J., Saunders, Tracie, Frankel, Melissa, Kareddula, Aparna, Damare, Sherrie, Wesolowsky, Elayne, Gabel, Christian, El-Deiry, Wafik S., Prabhu, Varun V., Allen, Joshua E., Stogniew, Martin, Oster, Wolfgang, Bertino, Joseph R., Libutti, Steven K., Mehnert, Janice M., and Zloza, Andrew

Published
2019
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27. RTID-01. ONC108: A RANDOMIZED PHASE 3 STUDY OF ONC201 IN PATIENTS WITH NEWLY DIAGNOSED H3 K27M-MUTANT DIFFUSE GLIOMA

Author

Arrillaga-Romany, Isabel, primary, Lassman, Andrew, additional, McGovern, Susan, additional, Mueller, Sabine, additional, Nabors, L Burt, additional, van den Bent, Martin, additional, Vogelbaum, Michael, additional, Allen, Joshua E, additional, Melemed, Allen, additional, Tarapore, Rohinton, additional, Yang, Dewen, additional, Wen, Patrick Y, additional, and Cloughesy, Timothy, additional

Published
2022
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28. CTNI-61. CLINICAL EFFICACY AND PREDICTIVE BIOMARKERS OF ONC201 IN H3K27M-MUTANT DIFFUSE MIDLINE GLIOMA

Author

Kawakibi, Abed Rahman, primary, Tarapore, Rohinton, additional, Gardner, Sharon, additional, Chi, Andrew, additional, Kurz, Sylvia, additional, Wen, Patrick Y, additional, Arrillaga-Romany, Isabel, additional, Batchelor, Tracy, additional, Butowski, Nicholas, additional, Sumrall, Ashley, additional, Shonka, Nicole, additional, Harrison, Rebecca, additional, DeGroot, John, additional, Mehta, Minesh, additional, Odia, Yazmin, additional, Hall, Matthew, additional, Daghistani, Doured, additional, Cloughesy, Timothy, additional, Ellingson, Benjamin, additional, Kim, Michelle, additional, Umemura, Yoshie, additional, Garton, Hugh, additional, Franson, Andrea, additional, Schwartz, Jonathan, additional, Li, Sunjong, additional, Cartaxo, Rodrigo, additional, Ravi, Karthik, additional, Cantor, Evan, additional, Cummings, Jessica, additional, Paul, Alyssa, additional, Walling, Dustin, additional, Dun, Matthew, additional, Cain, Jason, additional, Li, Jiang, additional, Filbin, Mariella, additional, Zhao, Lili, additional, Kumar-Sinha, Chandan, additional, Mody, Rajen, additional, Chinnaiyan, Arul, additional, Kurokawa, Ryo, additional, Pratt, Drew, additional, Venneti, Sriram, additional, Grill, Jacques, additional, Kline, Cassie, additional, Mueller, Sabine, additional, Resnick, Adam C, additional, Nazarian, Javad, additional, Waszak, Sebastian, additional, Allen, Joshua E, additional, and Koschmann, Carl, additional

Published
2022
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30. Erratum. Foxo1 Inhibits Diabetic Mucosal Wound Healing but Enhances Healing of Normoglycemic Wounds. Diabetes 2015;64:243–256

Author

Xu, Fanxing, primary, Othman, Badr, additional, Lim, Jason, additional, Batres, Angelika, additional, Ponugoti, Bhaskar, additional, Zhang, Chenying, additional, Yi, Leah, additional, Liu, Jian, additional, Tian, Chen, additional, Hameedaldeen, Alhassan, additional, Alsadun, Sarah, additional, Tarapore, Rohinton, additional, and Graves, Dana T., additional

Published
2022
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31. SYST-14 CLINICAL EFFICACY OF ONC201 IN RECURRENT H3 K27M-MUTANT DIFFUSE MIDLINE GLIOMA (DMG) PATIENTS

Author

Arrillaga-Romany, Isabel, primary, Kurz, Sylvia, additional, Tarapore, Rohinton, additional, Lu, Guangrong, additional, Sumrall, Ashley, additional, Butowski, Nicholas, additional, Harrison, Rebecca, additional, DeGroot, John, additional, Chi, Andrew, additional, Shonka, Nicole, additional, Umemura, Yoshie, additional, Odia, Yazmin, additional, Mehta, Minesh, additional, Nghiemphu, Phioanh, additional, Cloughesy, Timothy, additional, Taylor, Lynne, additional, Graber, Jerome, additional, Kilburn, Lindsay, additional, Dixit, Karan, additional, Chen, Clark, additional, Gardner, Sharon, additional, Aguilera, Dolly, additional, MacDonald, Tobey, additional, Cluster, Andrew, additional, Mehta, Kathan, additional, Kheradpour, Albert, additional, Melemed, Allen, additional, Allen, Joshua E, additional, Batchelor, Tracey, additional, Lassman, Andrew, additional, and Wen, Patrick, additional

Published
2022
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32. SYST-07 WINDOW-OF-OPPORTUNITY STUDY OF ONC201 IN PEDIATRIC PATIENTS WITH DIFFUSE INTRINSIC PONTINE GLIOMA (DIPG) AND THALAMIC GLIOMA

Author

Odia, Yazmin, primary, Koschmann, Carl, additional, Tarapore, Rohinton, additional, Allen, Jeffrey, additional, Hall, Matthew, additional, Daghistani, Doured, additional, Khatib, Ziad, additional, Aguilera, Dolly, additional, MacDonald, Tobey, additional, de Blank, Peter, additional, McGovern, Susan Lynne, additional, Mueller, Sabine, additional, Kline, Cassie, additional, Vitanza, Nicholas, additional, Allen, Joshua E, additional, Zaky, Wafik, additional, and Gardner, Sharon, additional

Published
2022
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33. Window-of-opportunity study of ONC201 in pediatric patients with diffuse intrinsic pontine glioma (DIPG) and thalamic glioma.

Author

Odia, Yazmin, primary, Koschmann, Carl Johannes, additional, Tarapore, Rohinton, additional, Allen, Jeffrey, additional, Zaky, Wafik Tharwat, additional, Hall, Matthew David, additional, Daghistani, Doured, additional, Khatib, Ziad, additional, Aguilera, Dolly, additional, MacDonald, Tobey J., additional, de Blank, Peter, additional, McGovern, Susan L., additional, Mueller, Sabine, additional, Kline, Cassie, additional, Vitanza, Nicholas A., additional, Allen, Joshua E., additional, and Gardner, Sharon L., additional

Published
2022
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35. Serial H3K27M cell-free tumor DNA (cf-tDNA) tracking predicts ONC201 treatment response and progression in diffuse midline glioma

Author

Cantor, Evan, primary, Wierzbicki, Kyle, additional, Tarapore, Rohinton S, additional, Ravi, Karthik, additional, Thomas, Chase, additional, Cartaxo, Rodrigo, additional, Nand Yadav, Viveka, additional, Ravindran, Ramya, additional, Bruzek, Amy K, additional, Wadden, Jack, additional, John, Vishal, additional, May Babila, Clarissa, additional, Cummings, Jessica R, additional, Rahman Kawakibi, Abed, additional, Ji, Sunjong, additional, Ramos, Johanna, additional, Paul, Alyssa, additional, Walling, Dustin, additional, Leonard, Marcia, additional, Robertson, Patricia, additional, Franson, Andrea, additional, Mody, Rajen, additional, Garton, Hugh J L, additional, Venneti, Sriram, additional, Odia, Yazmin, additional, Kline, Cassie, additional, Vitanza, Nicholas A, additional, Khatua, Soumen, additional, Mueller, Sabine, additional, Allen, Joshua E, additional, Gardner, Sharon L, additional, and Koschmann, Carl, additional

Published
2022
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36. Phase II Study of ONC201 in Neuroendocrine Tumors including Pheochromocytoma-Paraganglioma and Desmoplastic Small Round Cell Tumor

Author

Anderson, Peter M., primary, Trucco, Matteo M., additional, Tarapore, Rohinton S., additional, Zahler, Stacey, additional, Thomas, Stefanie, additional, Gortz, Janette, additional, Mian, Omar, additional, Stoignew, Martin, additional, Prabhu, Varun, additional, Morrow, Sara, additional, and Allen, Joshua E., additional

Published
2022
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37. Phase I dose escalation and expansion trial of single agent ONC201 in pediatric diffuse midline gliomas following radiotherapy

Author

Gardner, Sharon L, primary, Tarapore, Rohinton S, additional, Allen, Jeffrey, additional, McGovern, Susan L, additional, Zaky, Wafik, additional, Odia, Yazmin, additional, Daghistani, Doured, additional, Diaz, Zuanel, additional, Hall, Matthew D, additional, Khatib, Ziad, additional, Koschmann, Carl, additional, Cantor, Evan, additional, Kurokawa, Ryo, additional, MacDonald, Tobey J, additional, Aguilera, Dolly, additional, Vitanza, Nicholas A, additional, Mueller, Sabine, additional, Kline, Cassie, additional, Lu, Guangrong, additional, Allen, Joshua E, additional, and Khatua, Soumen, additional

Published
2022
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38. CTNI-36. SAFETY OF ONC201 ADMINISTERED TWO CONSECUTIVE DAYS PER WEEK IN PEDIATRIC H3 K27M-MUTANT GLIOMA PATIENTS

Author

Gardner, Sharon, primary, Koschmann, Carl, additional, Tarapore, Rohinton, additional, Allen, Jeffrey, additional, Zaky, Wafik, additional, Odia, Yazmin, additional, Hall, Matthew, additional, Daghistani, Doured, additional, Khatib, Ziad, additional, Aguilera, Dolly, additional, MacDonald, Tobey, additional, de Blank, Peter, additional, McGovern, Susan, additional, Mueller, Sabine, additional, Kline, Cassie, additional, Vitanza, Nicholas, additional, Allen, Joshua, additional, and Khatua, Soumen, additional

Published
2021
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39. CTNI-27. SINGLE AGENT ACTIVITY OF ONC201 IN NON-MIDLINE H3 K27M-MUTANT DIFFUSE GLIOMAS

Author

Odia, Yazmin, primary, Sumrall, Ashley, additional, Cloughesy, Timothy, additional, Nghiemphu, Phioanh, additional, Hall, Matthew, additional, Daghistani, Doured, additional, Mehta, Minesh, additional, Lassman, Andrew, additional, Arrillaga-Romany, Isabel, additional, Gardner, Sharon, additional, Tarapore, Rohinton, additional, Lu, Guangrong, additional, Allen, Joshua, additional, and Wen, Patrick, additional

Published
2021
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40. BIOM-28. SERIAL PLASMA AND CSF CELL-FREE TUMOR DNA (cf-tDNA) TRACKING IN DIFFUSE MIDLINE GLIOMA PATIENTS UNDERGOING TREATMENT WITH ONC201

Author

Cantor, Evan, primary, Wierzbicki, Kyle, additional, Tarapore, Rohinton, additional, Ravi, Karthik, additional, Wadden, Jack, additional, Babilla, Clarissa, additional, Thomas, Chase, additional, Cartaxo, Rodrigo, additional, Yadav, Vivek Anand, additional, Ravindran, Ramya, additional, Bruzek, Amy K, additional, Cummings, Jessica, additional, Kawakibi, Abed Rahman, additional, Ji, Sunjong, additional, Paul, Alyssa, additional, Wolfe, Ian, additional, Leonard, Marcia, additional, Robertson, Patricia, additional, Franson, Andrea, additional, Mody, Rajen, additional, Garton, Hugh, additional, Odia, Yazmin, additional, Kline, Cassie, additional, Vitanza, Nicholas, additional, Khatua, Soumen, additional, Allen, Joshua, additional, Mueller, Sabine, additional, Gardner, Sharon, additional, and Koschmann, Carl, additional

Published
2021
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44. EPCT-03. SERIAL PLASMA AND CSF CELL-FREE TUMOR DNA (CF-TDNA) TRACKING IN DIFFUSE MIDLINE GLIOMA PATIENTS UNDERGOING TREATMENT WITH ONC201

Author

Cantor, Evan, primary, Wierzbicki, Kyle, additional, Tarapore, Rohinton S, additional, Thomas, Chase, additional, Cartaxo, Rodrigo, additional, Yadav, Viveka Nand, additional, Ravindran, Ramya, additional, Bruzek, Amy K, additional, Wadden, Jack, additional, Babilla, Clarissa May, additional, Kawakibi, Abed Rhaman, additional, Ji, Sunjong, additional, Ramos, Johanna, additional, Paul, Alyssa, additional, Wolfe, Ian, additional, Leonard, Marcia, additional, Robertson, Partricia, additional, Franson, Andrea, additional, Mody, Rajen, additional, Garton, Hugh, additional, Odia, Yazmin, additional, Kline, Cassie, additional, Vitanza, Nicholas A, additional, Khatua, Soumen, additional, Mueller, Sabine, additional, Allen, Joshua E, additional, Gardner, Sharon, additional, and Koschmann, Carl, additional

Published
2021
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45. Single agent activity of ONC201 in non-midline H3 K27M-mutant diffuse gliomas.

Author

Odia, Yazmin, primary, Sumrall, Ashley Love, additional, Cloughesy, Timothy Francis, additional, Nghiemphu, Phioanh Leia Leia, additional, Hall, Matthew David, additional, Daghistani, Doured, additional, Mehta, Minesh P., additional, Lassman, Andrew B., additional, Arrillaga-Romany, Isabel, additional, Gardner, Sharon L., additional, Tarapore, Rohinton, additional, Lu, Guangrong, additional, Allen, Joshua E., additional, and Wen, Patrick Y., additional

Published
2021
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46. Serial plasma and CSF cell-free tumor DNA (cf-tDNA) tracking in diffuse midline glioma patients undergoing treatment with ONC201.

Author

Cantor, Evan, primary, Wierzbicki, Kyle, additional, Tarapore, Rohinton, additional, Thomas, Chase, additional, Cartaxo, Rodrigo, additional, Yadav, Viveka Nand, additional, Ravindran, Ramya, additional, Bruzek, Amy, additional, Franson, Andrea, additional, Mody, Rajen, additional, Garton, Hugh, additional, Odia, Yazmin, additional, Kline, Cassie, additional, Vitanza, Nicholas A, additional, Khatua, Soumen, additional, Mueller, Sabine, additional, Allen, Joshua E., additional, Gardner, Sharon L., additional, and Koschmann, Carl Johannes, additional

Published
2021
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47. Correction: Hu, W., et al. Targeting Dopamine Receptor D2 by Imipridone Suppresses Uterine Serous Cancer Malignant Phenotype. Cancers 2020, 12, 2436

Author

Hu, Wen, primary, Zhang, Li, additional, Ferri-Borgogno, Sammy, additional, Kwan, Suet-Ying, additional, Lewis, Kelsey E., additional, Cun, Han T., additional, Yeung, Tsz-Lun, additional, Soliman, Pamela T., additional, Tarapore, Rohinton S., additional, Allen, Joshua E., additional, Guan, Xinyuan, additional, Lu, Karen H., additional, Mok, Samuel C., additional, and Au-Yeung, Chi-Lam, additional

Published
2021
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48. ONC201 Shows Potent Anticancer Activity Against Medullary Thyroid Cancer via Transcriptional Inhibition of RET, VEGFR2, and IGFBP2

Author

Bagheri-Yarmand, Rozita, primary, Dadu, Ramona, additional, Ye, Lei, additional, Shiny Jebaraj, Yaashmin, additional, Martinez, Jade A., additional, Ma, Junsheng, additional, Tarapore, Rohinton S., additional, Allen, Joshua E., additional, Sherman, Steven I., additional, Williams, Michelle D., additional, and Gagel, Robert F., additional

Published
2021
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