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2. Palbociclib in Solid Tumor Patients With Genomic Alterations in the cyclinD-cdk4/6-INK4a-Rb Pathway: Results From National Cancer Institute-Childrenʼs Oncology Group Pediatric Molecular Analysis for Therapy Choice Trial Arm I (APEC1621I)

Author

Macy, Margaret E., Mody, Rajen, Reid, Joel M., Piao, Jin, Saguilig, Lauren, Alonzo, Todd A., Berg, Stacey L., Fox, Elizabeth, Weigel, Brenda J., Hawkins, Douglas S., Mooney, Margaret M., Williams, P. Mickey, Patton, David R., Coffey, Brent D., Roy-Chowdhuri, Sinchita, Takebe, Naoko, Tricoli, James V., Janeway, Katherine A., Seibel, Nita L., and Parsons, D. Williams

Published
2024
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3. Phase II Study of Samotolisib in Children and Young Adults With Tumors Harboring Phosphoinositide 3-Kinase/Mammalian Target of Rapamycin Pathway Alterations: Pediatric MATCH APEC1621D

Author

Laetsch, Theodore W., Ludwig, Kathleen, Williams, P. Mickey, Roy-Chowdhuri, Sinchita, Patton, David R., Coffey, Brent, Reid, Joel M., Piao, Jin, Saguilig, Lauren, Alonzo, Todd A., Berg, Stacey L., Mhlanga, Joyce, Fox, Elizabeth, Weigel, Brenda J., Hawkins, Douglas S., Mooney, Margaret M., Takebe, Naoko, Tricoli, James V., Janeway, Katherine A., Seibel, Nita L., and Parsons, Donald Williams

Published
2024
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4. Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A

Author

Gettinger, Scott N., Song, Zihe, Reckamp, Karen L., Moscow, Jeffrey A., Gray, Robert J., Wang, Victoria, McShane, Lisa M., Rubinstein, Larry V., Patton, David R., Williams, P. Mickey, Hamilton, Stanley R., Kong, Xiao-Tang, Tricoli, James V., Conley, Barbara A., Arteaga, Carlos L., Harris, Lyndsay N., OʼDwyer, Peter J., Chen, Alice P., and Flaherty, Keith T.

Published
2024
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5. Phase II Study of Ulixertinib in Children and Young Adults With Tumors Harboring Activating Mitogen-Activated Protein Kinase Pathway Alterations: APEC1621J of the National Cancer Institute-Childrenʼs Oncology Group Pediatric MATCH Trial

Author

Vo, Kieuhoa T., Sabnis, Amit J., Williams, P. Mickey, Roy-Chowdhuri, Sinchita, Patton, David R., Coffey, Brent, Reid, Joel M., Piao, Jin, Saguilig, Lauren, Alonzo, Todd A., Berg, Stacey L., Jaju, Alok, Fox, Elizabeth, Weigel, Brenda J., Hawkins, Douglas S., Mooney, Margaret M., Takebe, Naoko, Tricoli, James V., Janeway, Katherine A., Seibel, Nita L., and Parsons, D. Williams

Published
2024
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6. The NCI-MATCH trial: lessons for precision oncology

Author

O’Dwyer, Peter J., Gray, Robert J., Flaherty, Keith T., Chen, Alice P., Li, Shuli, Wang, Victoria, McShane, Lisa M., Patton, David R., Tricoli, James V., Williams, P. Mickey, Iafrate, A. John, Sklar, Jeffrey, Mitchell, Edith P., Takebe, Naoko, Sims, David J., Coffey, Brent, Fu, Tony, Routbort, Mark, Rubinstein, Larry V., Little, Richard F., Arteaga, Carlos L., Marinucci, Donna, Hamilton, Stanley R., Conley, Barbara A., Harris, Lyndsay N., and Doroshow, James H.

Published
2023
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7. Phase II Study of Erdafitinib in Patients With Tumors With Fibroblast Growth Factor Receptor Mutations or Fusions: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol K2

Author

Gong, Jun, Mita, Alain C., Wei, Zihan, Cheng, Heather H., Mitchell, Edith P., Wright, John J., Ivy, S. Percy, Wang, Victoria, Gray, Robert C., McShane, Lisa M., Rubinstein, Larry V., Patton, David R., Williams, P. Mickey, Hamilton, Stanley R., Tricoli, James V., Conley, Barbara A., Arteaga, Carlos L., Harris, Lyndsay N., OʼDwyer, Peter J., Chen, Alice P., and Flaherty, Keith T.

Published
2024
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8. Phase II Study of Erdafitinib in Patients With Tumors With FGFR Amplifications: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol K1

Author

Gong, Jun, Mita, Alain C., Wei, Zihan, Cheng, Heather H., Mitchell, Edith P., Wright, John J., Ivy, S. Percy, Wang, Victoria, Gray, Robert C., McShane, Lisa M., Rubinstein, Larry V., Patton, David R., Williams, P. Mickey, Hamilton, Stanley R., Alva, Ajjai S., Tricoli, James V., Conley, Barbara A., Arteaga, Carlos L., Harris, Lyndsay N., OʼDwyer, Peter J., Chen, Alice P., and Flaherty, Keith T.

Published
2024
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9. Phase II Study of Osimertinib in Patients With Epidermal Growth Factor Receptor Mutations: Results From the NCI-MATCH ECOG-ACRIN (EAY131) Trial Subprotocol E

Author

Chen, Monica F., Song, Zihe, Yu, Helena A., Sequist, Lecia V., Lovly, Christine M., Mitchell, Edith P., Moscow, Jeffrey A., Gray, Robert J., Wang, Victoria, McShane, Lisa M., Rubinstein, Larry V., Patton, David R., Williams, P. Mickey, Hamilton, Stanley R., Umemura, Yoshie, Tricoli, James V., Conley, Barbara A., Arteaga, Carlos L., Harris, Lyndsay N., OʼDwyer, Peter J., Chen, Alice P., and Flaherty, Keith T.

Published
2024
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10. Circulating tumor DNA sequencing provides comprehensive mutation profiling for pediatric central nervous system tumors

Author

Bonner, Erin R., Harrington, Robin, Eze, Augustine, Bornhorst, Miriam, Kline, Cassie N., Gordish-Dressman, Heather, Dawood, Adam, Das, Biswajit, Chen, Li, Pauly, Rini, Williams, P. Mickey, Karlovich, Chris, Peach, Amanda, Howell, D’andra, Doroshow, James, Kilburn, Lindsay, Packer, Roger J., Mueller, Sabine, and Nazarian, Javad

Published
2022
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11. Molecular profiling of plasma from matched NCI-MATCH gynecological cancers.

Author

Peach, Amanda, primary, Le, Bao, additional, Rahul Kannan, Vishnuprabha, additional, Greenbank, Eric, additional, Pauly, Rini, additional, Chen, Li, additional, Chang, Ting-Chia, additional, LoCoco, Jennifer S., additional, Harris, Lyndsay, additional, Chen, Alice P., additional, Takebe, Naoko, additional, Pawlowski, Traci L., additional, McShane, Lisa, additional, O'Dwyer, Peter J., additional, Doroshow, James H., additional, Williams, P. Mickey, additional, Das, Biswajit, additional, and Karlovich, Chris Alan, additional

Published
2024
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12. Trametinib in Patients With NF1-, GNAQ-, or GNA11-Mutant Tumors: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocols S1 and S2

Author

Wisinski, Kari B., Flamand, Yael, Wilson, Melissa A., Luke, Jason J., Tawbi, Hussein A., Hong, Fangxin, Mitchell, Edith P., Zwiebel, James A., Chen, Helen, Gray, Robert J., Li, Shuli, McShane, Lisa M., Rubinstein, Lawrence V., Patton, David, Williams, P. Mickey, Hamilton, Stanley R., Behrens, Robert J., Pennington, Kathryn P., Conley, Barbara A., Arteaga, Carlos L., Harris, Lyndsay N., OʼDwyer, Peter J., Chen, Alice P., and Flaherty, Keith T.

Published
2023
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13. Resource requirements to accelerate clinical applications of next-generation sequencing and radiomics: workshop commentary and review.

Author

Harris, Lyndsay, Shankar, Lalitha K, Hildebrandt, Claire, Rubinstein, Wendy S, Langlais, Kristofor, Rodriguez, Henry, Berger, Adam, Freymann, John, Huang, Erich P, Williams, P Mickey, Zenklusen, Jean Claude, Ochs, Robert, Tezak, Zivana, and Sahiner, Berkman

Subjects
NUCLEOTIDE sequencing, ARTIFICIAL intelligence, MACHINE learning, RADIOMICS, SCIENTIFIC community
Abstract

The National Institutes of Health–US Food and Drug Administration Joint Leadership Council Next-Generation Sequencing and Radiomics Working Group was formed by the National Institutes of Health–Food and Drug Administration Joint Leadership Council to promote the development and validation of innovative next-generation sequencing tests, radiomic tools, and associated data analysis and interpretation enhanced by artificial intelligence and machine learning technologies. A 2-day workshop was held on September 29-30, 2021, to convene members of the scientific community to discuss how to overcome the "ground truth" gap that has frequently been acknowledged as 1 of the limiting factors impeding high-quality research, development, validation, and regulatory science in these fields. This report provides a summary of the resource gaps identified by the working group and attendees, highlights existing resources and the ways they can potentially be employed to accelerate growth in these fields, and presents opportunities to support next-generation sequencing and radiomic tool development and validation using technologies such as artificial intelligence and machine learning. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Phase II Study of Afatinib in Patients With Tumors With Human Epidermal Growth Factor Receptor 2–Activating Mutations: Results From the National Cancer Institute–Molecular Analysis for Therapy Choice ECOG-ACRIN Trial (EAY131) Subprotocol EAY131-B

Author

Bedard, Philippe L., Li, Shuli, Wisinski, Kari B., Yang, Eddy S., Limaye, Sewanti A., Mitchell, Edith P., Zwiebel, James A., Moscow, Jeffrey A., Gray, Robert J., Wang, Victoria, McShane, Lisa M., Rubinstein, Larry V., Patton, David R., Williams, P. Mickey, Hamilton, Stanley R., Conley, Barbara A., Arteaga, Carlos L., Harris, Lyndsay N., OʼDwyer, Peter J., Chen, Alice P., and Flaherty, Keith T.

Published
2022
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15. Supplementary Figures 1 from Trastuzumab and Pertuzumab in Patients with Non-Breast/Gastroesophageal HER2-Amplified Tumors: Results from the NCI–MATCH ECOG–ACRIN Trial (EAY131) Subprotocol J

Author

Connolly, Roisin M., primary, Wang, Victoria, primary, Hyman, David M., primary, Grivas, Petros, primary, Mitchell, Edith P., primary, Wright, John J., primary, Sharon, Elad, primary, Gray, Robert J., primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David R., primary, Williams, P. Mickey, primary, Hamilton, Stanley R., primary, Wang, Jue, primary, Wisinski, Kari B., primary, Tricoli, James V., primary, Conley, Barbara A., primary, Harris, Lyndsay N., primary, Arteaga, Carlos L., primary, O'Dwyer, Peter J., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2024
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16. Supplementary tables 1 from Trastuzumab and Pertuzumab in Patients with Non-Breast/Gastroesophageal HER2-Amplified Tumors: Results from the NCI–MATCH ECOG–ACRIN Trial (EAY131) Subprotocol J

Author

Connolly, Roisin M., primary, Wang, Victoria, primary, Hyman, David M., primary, Grivas, Petros, primary, Mitchell, Edith P., primary, Wright, John J., primary, Sharon, Elad, primary, Gray, Robert J., primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David R., primary, Williams, P. Mickey, primary, Hamilton, Stanley R., primary, Wang, Jue, primary, Wisinski, Kari B., primary, Tricoli, James V., primary, Conley, Barbara A., primary, Harris, Lyndsay N., primary, Arteaga, Carlos L., primary, O'Dwyer, Peter J., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2024
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17. Data from Trastuzumab and Pertuzumab in Patients with Non-Breast/Gastroesophageal HER2-Amplified Tumors: Results from the NCI–MATCH ECOG–ACRIN Trial (EAY131) Subprotocol J

Author

Connolly, Roisin M., primary, Wang, Victoria, primary, Hyman, David M., primary, Grivas, Petros, primary, Mitchell, Edith P., primary, Wright, John J., primary, Sharon, Elad, primary, Gray, Robert J., primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David R., primary, Williams, P. Mickey, primary, Hamilton, Stanley R., primary, Wang, Jue, primary, Wisinski, Kari B., primary, Tricoli, James V., primary, Conley, Barbara A., primary, Harris, Lyndsay N., primary, Arteaga, Carlos L., primary, O'Dwyer, Peter J., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2024
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18. Trastuzumab and Pertuzumab in Patients with Non-Breast/Gastroesophageal HER2-Amplified Tumors: Results from the NCI–MATCH ECOG–ACRIN Trial (EAY131) Subprotocol J

Author

Connolly, Roisin M., primary, Wang, Victoria, additional, Hyman, David M., additional, Grivas, Petros, additional, Mitchell, Edith P., additional, Wright, John J., additional, Sharon, Elad, additional, Gray, Robert J., additional, McShane, Lisa M., additional, Rubinstein, Larry V., additional, Patton, David R., additional, Williams, P. Mickey, additional, Hamilton, Stanley R., additional, Wang, Jue, additional, Wisinski, Kari B., additional, Tricoli, James V., additional, Conley, Barbara A., additional, Harris, Lyndsay N., additional, Arteaga, Carlos L., additional, O'Dwyer, Peter J., additional, Chen, Alice P., additional, and Flaherty, Keith T., additional

Published
2024
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20. Multilaboratory Assessment of a New Reference Material for Quality Assurance of Cell-Free Tumor DNA Measurements

Author

He, Hua-Jun, Stein, Erica V., Konigshofer, Yves, Forbes, Thomas, Tomson, Farol L., Garlick, Russell, Yamada, Emiko, Godfrey, Tony, Abe, Toshiya, Tamura, Koji, Borges, Michael, Goggins, Michael, Elmore, Sandra, Gulley, Margaret L., Larson, Jessica L., Ringel, Lando, Haynes, Brian C., Karlovich, Chris, Williams, P. Mickey, Garnett, Aaron, Ståhlberg, Anders, Filges, Stefan, Sorbara, Lynn, Young, Mathew R., Srivastava, Sudhir, and Cole, Kenneth D.

Published
2019
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21. Phase II Study of Taselisib in PIK3CA-Mutated Solid Tumors Other Than Breast and Squamous Lung Cancer: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol I

Author

Krop, Ian E., Jegede, Opeyemi A., Grilley-Olson, Juneko E., Lauring, Josh D., Mitchell, Edith P., Zwiebel, James A., Gray, Robert J., Wang, Victoria, McShane, Lisa M., Rubinstein, Larry V., Patton, David, Williams, P. Mickey, Hamilton, Stanley R., Kono, Scott A., Ford, James M., Garcia, Agustin A., Sui, Xingwei D., Siegel, Robert D., Slomovitz, Brian M., Conley, Barbara A., Arteaga, Carlos L., Harris, Lyndsay N., OʼDwyer, Peter J., Chen, Alice P., and Flaherty, Keith T.

Published
2022
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22. Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration

Author

McShane, Lisa M, Cavenagh, Margaret M, Lively, Tracy G, Eberhard, David A, Bigbee, William L, Williams, P Mickey, Mesirov, Jill P, Polley, Mei-Yin C, Kim, Kelly Y, Tricoli, James V, Taylor, Jeremy MG, Shuman, Deborah J, Simon, Richard M, Doroshow, James H, and Conley, Barbara A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Cancer, Clinical Research, Generic health relevance, Good Health and Well Being, Biomedical Research, Clinical Trials as Topic, Genomics, Guidelines as Topic, High-Throughput Screening Assays, Humans, Precision Medicine, Reproducibility of Results, Research Design, Analytical validation, Biomarker, Diagnostic test, Genomic classifier, Model validation, Molecular profile, Omics, Personalized medicine, Treatment selection, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

High-throughput 'omics' technologies that generate molecular profiles for biospecimens have been extensively used in preclinical studies to reveal molecular subtypes and elucidate the biological mechanisms of disease, and in retrospective studies on clinical specimens to develop mathematical models to predict clinical endpoints. Nevertheless, the translation of these technologies into clinical tests that are useful for guiding management decisions for patients has been relatively slow. It can be difficult to determine when the body of evidence for an omics-based test is sufficiently comprehensive and reliable to support claims that it is ready for clinical use, or even that it is ready for definitive evaluation in a clinical trial in which it may be used to direct patient therapy. Reasons for this difficulty include the exploratory and retrospective nature of many of these studies, the complexity of these assays and their application to clinical specimens, and the many potential pitfalls inherent in the development of mathematical predictor models from the very high-dimensional data generated by these omics technologies. Here we present a checklist of criteria to consider when evaluating the body of evidence supporting the clinical use of a predictor to guide patient therapy. Included are issues pertaining to specimen and assay requirements, the soundness of the process for developing predictor models, expectations regarding clinical study design and conduct, and attention to regulatory, ethical, and legal issues. The proposed checklist should serve as a useful guide to investigators preparing proposals for studies involving the use of omics-based tests. The US National Cancer Institute plans to refer to these guidelines for review of proposals for studies involving omics tests, and it is hoped that other sponsors will adopt the checklist as well.

Published
2013

23. Criteria for the use of omics-based predictors in clinical trials

Author

McShane, Lisa M, Cavenagh, Margaret M, Lively, Tracy G, Eberhard, David A, Bigbee, William L, Williams, P Mickey, Mesirov, Jill P, Polley, Mei-Yin C, Kim, Kelly Y, Tricoli, James V, Taylor, Jeremy MG, Shuman, Deborah J, Simon, Richard M, Doroshow, James H, and Conley, Barbara A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Cancer, Good Health and Well Being, Checklist, Clinical Trials as Topic, Evaluation Studies as Topic, Genomics, Humans, Models, Biological, National Cancer Institute (U.S.), Precision Medicine, Research Design, Specimen Handling, United States, General Science & Technology
Abstract

The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to 'omics'-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.

Published
2013

25. Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial: Molecular Analysis for Therapy Choice Clinical Trial

Author

Lih, Chih-Jian, Harrington, Robin D., Sims, David J., Harper, Kneshay N., Bouk, Courtney H., Datta, Vivekananda, Yau, Jonathan, Singh, Rajesh R., Routbort, Mark J., Luthra, Rajyalakshmi, Patel, Keyur P., Mantha, Geeta S., Krishnamurthy, Savitri, Ronski, Karyn, Walther, Zenta, Finberg, Karin E., Canosa, Sandra, Robinson, Hayley, Raymond, Amelia, Le, Long P., McShane, Lisa M., Polley, Eric C., Conley, Barbara A., Doroshow, James H., Iafrate, A. John, Sklar, Jeffrey L., Hamilton, Stanley R., and Williams, P. Mickey

Published
2017
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26. Validation of ctDNA Quality Control Materials Through a Precompetitive Collaboration of the Foundation for the National Institutes of Health

Author

Williams, P. Mickey, Forbes, Thomas, P. Lund, Steven, Cole, Kenneth D., He, Hua-Jun, Karlovich, Chris, Paweletz, Cloud P., Stetson, Daniel, Yee, Laura M., Connors, Dana E., Keating, Susan M., Destenaves, Benoit, Cleveland, Megan H., Lau, Christie J., Barrett, J. Carl, Kelloff, Gary J., and McCormack, Robert T.

Published
2021
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27. Molecular Profiling-Based Assignment of Cancer Therapy (NCI-MPACT): A Randomized Multicenter Phase II Trial

Author

Chen, Alice P., Kummar, Shivaani, Moore, Nancy, Rubinstein, Lawrence V., Zhao, Yingdong, Williams, P. Mickey, Palmisano, Alida, Sims, David, OʼSullivan Coyne, Geraldine, Rosenberger, Christina L., Simpson, Mel, Raghav, Kanwal P. S., Meric-Bernstam, Funda, Leong, Stephen, Waqar, Saiama, Foster, Jared C., Konaté, Mariam M., Das, Biswajit, Karlovich, Chris, Lih, Chih-Jian, Polley, Eric, Simon, Richard, Li, Ming-Chung, Piekarz, Richard, and Doroshow, James H.

Published
2021
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29. Tazemetostat for Tumors Harboring SMARCB1/SMARCA4 or EZH2 Alterations: Results from NCI-COG Pediatric MATCH APEC1621C

Author

Chi, Susan N, primary, Yi, Joanna S, additional, Williams, P Mickey, additional, Roy-Chowdhuri, Sinchita, additional, Patton, David R, additional, Coffey, Brent D, additional, Reid, Joel M, additional, Piao, Jin, additional, Saguilig, Lauren, additional, Alonzo, Todd A, additional, Berg, Stacey L, additional, Ramirez, Nilsa C, additional, Jaju, Alok, additional, Mhlanga, Joyce C, additional, Fox, Elizabeth, additional, Hawkins, Douglas S, additional, Mooney, Margaret M, additional, Takebe, Naoko, additional, Tricoli, James V, additional, Janeway, Katherine A, additional, Seibel, Nita L, additional, and Parsons, D Williams, additional

Published
2023
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33. Phase II Study of Palbociclib (PD-0332991) in CCND1, 2, or 3 Amplification: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1B

Author

Clark, Amy S, Hong, Fangxin, Finn, Richard S, DeMichele, Angela M, Mitchell, Edith P, Zwiebel, James, Arnaldez, Fernanda I, Gray, Robert J, Wang, Victoria, McShane, Lisa M, Rubinstein, Larry V, Patton, David, Williams, P Mickey, Hamilton, Stanley R, Copur, Mehmet S, Kasbari, Samer S, Thind, Ravneet, Conley, Barbara A, Arteaga, Carlos L, O'Dwyer, Peter J, Harris, Lyndsay N, Chen, Alice P, Flaherty, Keith T, Clark, Amy S, Hong, Fangxin, Finn, Richard S, DeMichele, Angela M, Mitchell, Edith P, Zwiebel, James, Arnaldez, Fernanda I, Gray, Robert J, Wang, Victoria, McShane, Lisa M, Rubinstein, Larry V, Patton, David, Williams, P Mickey, Hamilton, Stanley R, Copur, Mehmet S, Kasbari, Samer S, Thind, Ravneet, Conley, Barbara A, Arteaga, Carlos L, O'Dwyer, Peter J, Harris, Lyndsay N, Chen, Alice P, and Flaherty, Keith T

Abstract

Purpose: Cyclin D/CDK4/6 is critical in controlling the G1 to S checkpoint. CCND, the gene encoding cyclin D, is known to be amplified in a variety of solid tumors. Palbociclib is an oral CDK4/6 inhibitor, approved in advanced breast cancer in combination with endocrine therapy. We explored the efficacy of palbociclib in patients with nonbreast solid tumors containing an amplification in CCND1, 2, or 3. Patients and methods: Patients with tumors containing a CCND1, 2, or 3 amplification and expression of the retinoblastoma protein were assigned to subprotocol Z1B and received palbociclib 125 mg once daily for 21 days of a 28-day cycle. Tumor response was assessed every two cycles. Results: Forty patients were assigned to subprotocol Z1B; 4 patients had outside assays identifying the CCND1, 2, or 3 amplification and were not confirmed centrally; 3 were ineligible and 2 were not treated (1 untreated patient was also ineligible), leaving 32 evaluable patients for this analysis. There were no partial responses; 12 patients (37.5%) had stable disease as best response. There were seven deaths on study, all during cycle 1 and attributable to disease progression. Median progression-free survival was 1.8 months. The most common toxicities were leukopenia (n = 21, 55%) and neutropenia (n = 19, 50%); neutropenia was the most common grade 3/4 event (n = 12, 32%). Conclusions: Palbociclib was not effective at treating nonbreast solid tumors with a CCND1, 2, or 3 amplification in this cohort. These data do not support further investigation of single-agent palbociclib in tumors with CCND1, 2, or 3 amplification.

Published
2023

34. Data from Phase II Study of Palbociclib (PD-0332991) in CCND1, 2, or 3 Amplification: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1B

Author

Clark, Amy S., primary, Hong, Fangxin, primary, Finn, Richard S., primary, DeMichele, Angela M., primary, Mitchell, Edith P., primary, Zwiebel, James, primary, Arnaldez, Fernanda I., primary, Gray, Robert J., primary, Wang, Victoria, primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David, primary, Williams, P. Mickey, primary, Hamilton, Stanley R., primary, Copur, Mehmet S., primary, Kasbari, Samer S., primary, Thind, Ravneet, primary, Conley, Barbara A., primary, Arteaga, Carlos L., primary, O'Dwyer, Peter J., primary, Harris, Lyndsay N., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2023
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35. Supplementary Table S1 from Phase II Study of Palbociclib (PD-0332991) in CCND1, 2, or 3 Amplification: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1B

Author

Clark, Amy S., primary, Hong, Fangxin, primary, Finn, Richard S., primary, DeMichele, Angela M., primary, Mitchell, Edith P., primary, Zwiebel, James, primary, Arnaldez, Fernanda I., primary, Gray, Robert J., primary, Wang, Victoria, primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David, primary, Williams, P. Mickey, primary, Hamilton, Stanley R., primary, Copur, Mehmet S., primary, Kasbari, Samer S., primary, Thind, Ravneet, primary, Conley, Barbara A., primary, Arteaga, Carlos L., primary, O'Dwyer, Peter J., primary, Harris, Lyndsay N., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2023
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36. Abstract 6072: Chromosomal aneuploidy, whole-genome doubling and mutational signatures in NCI PDMR models

Author

Chen, Li, primary, Das, Biswajit, additional, Chang, Ting-Chia, additional, Evrard, Yvonne A., additional, Karlovich, Chris A., additional, Chapman, Alyssa, additional, Fullmer, Brandie, additional, Hayes, Ashley, additional, Thornton, Ruth, additional, Nair, Nikitha, additional, Jiwani, Shahanawaz, additional, Dutko, Lindsay, additional, Benauer, Kelly, additional, Rivera, Gloryvee, additional, Camalier, Corinne, additional, Carter, John, additional, Borgel, Suzanne, additional, Miner, Tiffanie, additional, McGlynn, Chelsea, additional, Mills, Justine, additional, Uzelac, Shannon, additional, Shearer, Tia, additional, Hicks, Lauren, additional, Norris, Michelle, additional, Border, Carley, additional, Alcoser, Sergio, additional, Walsh, Thomas, additional, Mullendore, Michael, additional, Eugeni, Michelle, additional, Newton, Dianne, additional, Hollingshead, Melinda G., additional, Williams, P. Mickey, additional, and Doroshow, James H., additional

Published
2023
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37. Supplementary Table 1 from A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Author

Czuczman, Myron S., primary, Trněný, Marek, primary, Davies, Andrew, primary, Rule, Simon, primary, Linton, Kim M., primary, Wagner-Johnston, Nina, primary, Gascoyne, Randy D., primary, Slack, Graham W., primary, Brousset, Pierre, primary, Eberhard, David A., primary, Hernandez-Ilizaliturri, Francisco J., primary, Salles, Gilles, primary, Witzig, Thomas E., primary, Zinzani, Pier Luigi, primary, Wright, George W., primary, Staudt, Louis M., primary, Yang, Yandan, primary, Williams, P. Mickey, primary, Lih, Chih-Jian, primary, Russo, Jacqueline, primary, Thakurta, Anjan, primary, Hagner, Patrick, primary, Fustier, Pierre, primary, Song, Dale, primary, and Lewis, Ian D., primary

Published
2023
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38. Supplementary Table 2 from A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Author

Czuczman, Myron S., primary, Trněný, Marek, primary, Davies, Andrew, primary, Rule, Simon, primary, Linton, Kim M., primary, Wagner-Johnston, Nina, primary, Gascoyne, Randy D., primary, Slack, Graham W., primary, Brousset, Pierre, primary, Eberhard, David A., primary, Hernandez-Ilizaliturri, Francisco J., primary, Salles, Gilles, primary, Witzig, Thomas E., primary, Zinzani, Pier Luigi, primary, Wright, George W., primary, Staudt, Louis M., primary, Yang, Yandan, primary, Williams, P. Mickey, primary, Lih, Chih-Jian, primary, Russo, Jacqueline, primary, Thakurta, Anjan, primary, Hagner, Patrick, primary, Fustier, Pierre, primary, Song, Dale, primary, and Lewis, Ian D., primary

Published
2023
Full Text
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39. Supplementary Data from Trametinib Activity in Patients with Solid Tumors and Lymphomas Harboring BRAF Non-V600 Mutations or Fusions: Results from NCI-MATCH (EAY131)

Author

Johnson, Douglas B., primary, Zhao, Fengmin, primary, Noel, Marcus, primary, Riely, Gregory J., primary, Mitchell, Edith P., primary, Wright, John J., primary, Chen, Helen X., primary, Gray, Robert J., primary, Li, Shuli, primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David, primary, Williams, P. Mickey, primary, Hamilton, Stanly R., primary, Conley, Barbara A., primary, Arteaga, Carlos L., primary, Harris, Lyndsay N., primary, O'Dwyer, Peter J., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2023
Full Text
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40. Supplementary Expression Data from Randomized Trial of Oral Cyclophosphamide and Veliparib in High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers, or BRCA-Mutant Ovarian Cancer

Author

Kummar, Shivaani, primary, Oza, Amit M., primary, Fleming, Gini F., primary, Sullivan, Daniel M., primary, Gandara, David R., primary, Naughton, Michael J., primary, Villalona-Calero, Miguel A., primary, Morgan, Robert J., primary, Szabo, Peter M., primary, Youn, Ahrim, primary, Chen, Alice P., primary, Ji, Jiuping, primary, Allen, Deborah E., primary, Lih, Chih-Jian, primary, Mehaffey, Michele G., primary, Walsh, William D., primary, McGregor, Paul M., primary, Steinberg, Seth M., primary, Williams, P. Mickey, primary, Kinders, Robert J., primary, Conley, Barbara A., primary, Simon, Richard M., primary, and Doroshow, James H., primary

Published
2023
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41. Figure S3 from Randomized Trial of Oral Cyclophosphamide and Veliparib in High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers, or BRCA-Mutant Ovarian Cancer

Author

Kummar, Shivaani, primary, Oza, Amit M., primary, Fleming, Gini F., primary, Sullivan, Daniel M., primary, Gandara, David R., primary, Naughton, Michael J., primary, Villalona-Calero, Miguel A., primary, Morgan, Robert J., primary, Szabo, Peter M., primary, Youn, Ahrim, primary, Chen, Alice P., primary, Ji, Jiuping, primary, Allen, Deborah E., primary, Lih, Chih-Jian, primary, Mehaffey, Michele G., primary, Walsh, William D., primary, McGregor, Paul M., primary, Steinberg, Seth M., primary, Williams, P. Mickey, primary, Kinders, Robert J., primary, Conley, Barbara A., primary, Simon, Richard M., primary, and Doroshow, James H., primary

Published
2023
Full Text
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42. Supplementary Tables 1-4 from Trametinib Activity in Patients with Solid Tumors and Lymphomas Harboring BRAF Non-V600 Mutations or Fusions: Results from NCI-MATCH (EAY131)

Author

Johnson, Douglas B., primary, Zhao, Fengmin, primary, Noel, Marcus, primary, Riely, Gregory J., primary, Mitchell, Edith P., primary, Wright, John J., primary, Chen, Helen X., primary, Gray, Robert J., primary, Li, Shuli, primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David, primary, Williams, P. Mickey, primary, Hamilton, Stanly R., primary, Conley, Barbara A., primary, Arteaga, Carlos L., primary, Harris, Lyndsay N., primary, O'Dwyer, Peter J., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2023
Full Text
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43. Supplementary Table 3 from A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Author

Czuczman, Myron S., primary, Trněný, Marek, primary, Davies, Andrew, primary, Rule, Simon, primary, Linton, Kim M., primary, Wagner-Johnston, Nina, primary, Gascoyne, Randy D., primary, Slack, Graham W., primary, Brousset, Pierre, primary, Eberhard, David A., primary, Hernandez-Ilizaliturri, Francisco J., primary, Salles, Gilles, primary, Witzig, Thomas E., primary, Zinzani, Pier Luigi, primary, Wright, George W., primary, Staudt, Louis M., primary, Yang, Yandan, primary, Williams, P. Mickey, primary, Lih, Chih-Jian, primary, Russo, Jacqueline, primary, Thakurta, Anjan, primary, Hagner, Patrick, primary, Fustier, Pierre, primary, Song, Dale, primary, and Lewis, Ian D., primary

Published
2023
Full Text
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44. Supplementary Methods, Tables S1 and S2, Figure Legend from Randomized Trial of Oral Cyclophosphamide and Veliparib in High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers, or BRCA-Mutant Ovarian Cancer

Author

Kummar, Shivaani, primary, Oza, Amit M., primary, Fleming, Gini F., primary, Sullivan, Daniel M., primary, Gandara, David R., primary, Naughton, Michael J., primary, Villalona-Calero, Miguel A., primary, Morgan, Robert J., primary, Szabo, Peter M., primary, Youn, Ahrim, primary, Chen, Alice P., primary, Ji, Jiuping, primary, Allen, Deborah E., primary, Lih, Chih-Jian, primary, Mehaffey, Michele G., primary, Walsh, William D., primary, McGregor, Paul M., primary, Steinberg, Seth M., primary, Williams, P. Mickey, primary, Kinders, Robert J., primary, Conley, Barbara A., primary, Simon, Richard M., primary, and Doroshow, James H., primary

Published
2023
Full Text
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45. Supplementary Figure Legend from Differential Outcomes in Codon 12/13 and Codon 61 NRAS-Mutated Cancers in the Phase II NCI-MATCH Trial of Binimetinib in Patients with NRAS-Mutated Tumors

Author

Cleary, James M., primary, Wang, Victoria, primary, Heist, Rebecca S., primary, Kopetz, E. Scott, primary, Mitchell, Edith P., primary, Zwiebel, James A., primary, Kapner, Kevin S., primary, Chen, Helen X., primary, Li, Shuli, primary, Gray, Robert J., primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David R., primary, Meric-Bernstam, Funda, primary, Dillmon, Melissa S., primary, Williams, P. Mickey, primary, Hamilton, Stanley R., primary, Conley, Barbara A., primary, Aguirre, Andrew J., primary, O'Dwyer, Peter J., primary, Harris, Lyndsay N., primary, Arteaga, Carlos L., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2023
Full Text
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46. Supplemental Figures from Differential Outcomes in Codon 12/13 and Codon 61 NRAS-Mutated Cancers in the Phase II NCI-MATCH Trial of Binimetinib in Patients with NRAS-Mutated Tumors

Author

Cleary, James M., primary, Wang, Victoria, primary, Heist, Rebecca S., primary, Kopetz, E. Scott, primary, Mitchell, Edith P., primary, Zwiebel, James A., primary, Kapner, Kevin S., primary, Chen, Helen X., primary, Li, Shuli, primary, Gray, Robert J., primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David R., primary, Meric-Bernstam, Funda, primary, Dillmon, Melissa S., primary, Williams, P. Mickey, primary, Hamilton, Stanley R., primary, Conley, Barbara A., primary, Aguirre, Andrew J., primary, O'Dwyer, Peter J., primary, Harris, Lyndsay N., primary, Arteaga, Carlos L., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2023
Full Text
View/download PDF

47. Data from Randomized Trial of Oral Cyclophosphamide and Veliparib in High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers, or BRCA-Mutant Ovarian Cancer

Author

Kummar, Shivaani, primary, Oza, Amit M., primary, Fleming, Gini F., primary, Sullivan, Daniel M., primary, Gandara, David R., primary, Naughton, Michael J., primary, Villalona-Calero, Miguel A., primary, Morgan, Robert J., primary, Szabo, Peter M., primary, Youn, Ahrim, primary, Chen, Alice P., primary, Ji, Jiuping, primary, Allen, Deborah E., primary, Lih, Chih-Jian, primary, Mehaffey, Michele G., primary, Walsh, William D., primary, McGregor, Paul M., primary, Steinberg, Seth M., primary, Williams, P. Mickey, primary, Kinders, Robert J., primary, Conley, Barbara A., primary, Simon, Richard M., primary, and Doroshow, James H., primary

Published
2023
Full Text
View/download PDF

48. Supplementary Legend from Trametinib Activity in Patients with Solid Tumors and Lymphomas Harboring BRAF Non-V600 Mutations or Fusions: Results from NCI-MATCH (EAY131)

Author

Johnson, Douglas B., primary, Zhao, Fengmin, primary, Noel, Marcus, primary, Riely, Gregory J., primary, Mitchell, Edith P., primary, Wright, John J., primary, Chen, Helen X., primary, Gray, Robert J., primary, Li, Shuli, primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David, primary, Williams, P. Mickey, primary, Hamilton, Stanly R., primary, Conley, Barbara A., primary, Arteaga, Carlos L., primary, Harris, Lyndsay N., primary, O'Dwyer, Peter J., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2023
Full Text
View/download PDF

49. Supplemental Table from Differential Outcomes in Codon 12/13 and Codon 61 NRAS-Mutated Cancers in the Phase II NCI-MATCH Trial of Binimetinib in Patients with NRAS-Mutated Tumors

Author

Cleary, James M., primary, Wang, Victoria, primary, Heist, Rebecca S., primary, Kopetz, E. Scott, primary, Mitchell, Edith P., primary, Zwiebel, James A., primary, Kapner, Kevin S., primary, Chen, Helen X., primary, Li, Shuli, primary, Gray, Robert J., primary, McShane, Lisa M., primary, Rubinstein, Larry V., primary, Patton, David R., primary, Meric-Bernstam, Funda, primary, Dillmon, Melissa S., primary, Williams, P. Mickey, primary, Hamilton, Stanley R., primary, Conley, Barbara A., primary, Aguirre, Andrew J., primary, O'Dwyer, Peter J., primary, Harris, Lyndsay N., primary, Arteaga, Carlos L., primary, Chen, Alice P., primary, and Flaherty, Keith T., primary

Published
2023
Full Text
View/download PDF

50. Supplementary Figure 1 from A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Author

Czuczman, Myron S., primary, Trněný, Marek, primary, Davies, Andrew, primary, Rule, Simon, primary, Linton, Kim M., primary, Wagner-Johnston, Nina, primary, Gascoyne, Randy D., primary, Slack, Graham W., primary, Brousset, Pierre, primary, Eberhard, David A., primary, Hernandez-Ilizaliturri, Francisco J., primary, Salles, Gilles, primary, Witzig, Thomas E., primary, Zinzani, Pier Luigi, primary, Wright, George W., primary, Staudt, Louis M., primary, Yang, Yandan, primary, Williams, P. Mickey, primary, Lih, Chih-Jian, primary, Russo, Jacqueline, primary, Thakurta, Anjan, primary, Hagner, Patrick, primary, Fustier, Pierre, primary, Song, Dale, primary, and Lewis, Ian D., primary

Published
2023
Full Text
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