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2. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer.

Author

Drilon, A., Camidge, D. R., Lin, J. J., Kim, S.-W., Solomon, B. J., Dziadziuszko, R., Besse, B., Goto, K., de Langen, A. J., Wolf, J., Lee, K. H., Popat, S., Springfeld, C., Nagasaka, M., Felip, E., Yang, N., Velcheti, V., Lu, S., Kao, S., and Dooms, C.

Subjects
*NON-small-cell lung carcinoma, *ADVERSE health care events, *PROTEIN-tyrosine kinase inhibitors, *PROGRESSION-free survival, *PATIENT safety
Abstract

BACKGROUND The early-generation ROSl tyrosine kinase inhibitors (TKIs) that are approved for the treatment of ROS1 fusion-positive non-small-cell lung cancer (NSCLC) have antitumor activity, but resistance develops in tumors, and intracranial activity is suboptimal. Repotrectinib is a next-generation ROSl TKI with preclinical activity against ROSI fusion-positive cancers, including those with resistance mutations such as ROS1 62032. METHODS In this registrational phase 1-2 trial, we assessed the efficacy and safety of repotrec-tinib in patients with advanced solid tumors, including ROS1 fusion-positive NSCLC. The primary efficacy end point in the phase 2 trial was confirmed objective response; efficacy analyses included patients from phase 1 and phase 2. Duration of response, progression-free survival, and safety were secondary end points in phase 2. RESULTS On the basis of results from the phase 1 trial, the recommended phase 2 dose of repotrectinib was 160 mg daily for 14 days, followed by 160 mg twice daily. Response occurred in 56 of the 71 patients (79°/o; 95°6 confidence interval [CI], 68 to 88) with ROS1 fusion-positive NSCLC who had not previously received a ROS1 TKI; the median duration of response was 34.1 months (95% CI, 25.6 to could not be estimated), and median progression-free survival was 35.7 months (95% CI, 27.4 to could not be estimated). Response occurred in 21 of the 56 patients (3896; 95% CI, 25 to 52) with ROS1 fusion-positive NSCLC who had previously received one ROSl TKI and had never received chemotherapy; the median duration of response was 14.8 months (95% CI, 7.6 to could not be estimated), and median progression-free survival was 9.0 months (95% CI, 6.8 to 19.6). Ten of the 17 patients (5996; 95% CI, 33 to 82) with the ROS1 G2032R mutation had a response. A total of 426 patients received the phase 2 dose; the most common treatment-related adverse events were dizziness (in 58% of the patients), dysgeusia (in 5090), and paresthesia (in 30°6), and 3% discontinued repotrectinib owing to treatment-related adverse events. CONCLUSIONS Repotrectinib had durable clinical activity iii patients with ROS1 fusion-positive NSCLC, regardless of whether they had previously received a ROS1 TKI. Adverse events were mainly of low grade and compatible with long-term administration. (Funded by Turning Point Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb; TRIDENT-1 ClinicalTrials.gov number, NCT03093116.). [ABSTRACT FROM AUTHOR]

Published
2024
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13. Abstract CT169: A phase Ia study to evaluate RO7198457, an individualized Neoantigen Specific immunoTherapy (iNeST), in patients with locally advanced or metastatic solid tumors

Author

Braiteh, Fadi, primary, LoRusso, Patricia, additional, Balmanoukian, Ani, additional, Klempner, Sam, additional, Camidge, D R., additional, Hellmann, Matthew, additional, Gordon, Michael, additional, Bendell, Johanna, additional, Mueller, Lars, additional, Sabado, Rachel, additional, Twomey, Patrick, additional, Delamarre, Leila, additional, Huang, Jack, additional, Yadav, Mahesh, additional, Zhang, Jingbin, additional, McDonald, Patrick, additional, Müller, Felicitas, additional, Derhovanessian, Evelyna, additional, Türeci, Özlem, additional, Sahin, Ugur, additional, and Siu, Lillian, additional

Published
2020
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17. Immunotherapy for Non-Small Cell Lung Cancers (NSCLC) with Oncogenic Driver Mutations : New Results from the Global IMMUNOTARGET Registry

Author

Gautschi, O., Drilon, A., Milia, J., Lusque, A., Mhanna, L., Li, B., Sabari, J., Cortot, A., Besse, B., Mezquita, L., Solomon, B., Thai, A., Couraud, S., Veilion, R., Mascaux, C., Barlesi, F., Van den Heuvel, M., Schouten, R., Wakelee, H., Mah, A., Camidge, D. R., Ng, T., Peled, N., Lilach, Y., Popat, S., Ou, S., Zhu, V., Velcheti, V., Fontecedro, A. C., Akhoundova, D., Fruh, M., Zalcman, G., Gounant, V., Novello, S., Bironzo, P., Felip, E., Martinez-Marti, A., Moro-Sibilot, D., Rosell, R., Karachaliou, N., Schuler, Martin, Wiesweg, Marcel, Diebold, J., and Mazieres, J.

Subjects
Medizin
Published
2018

19. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study.

Author

Mok, T., Camidge, D. R., Gadgeel, S. M., Rosell, R., Dziadziuszko, R., Kim, D.-W., Pérol, M., Ou, S.-H. I., Ahn, J. S., Shaw, A. T., Bordogna, W., Smoljanović, V., Hilton, M., Ruf, T., Noé, J., and Peters, S.

Subjects
*NON-small-cell lung carcinoma, *PROGRESSION-free survival, *PROTEIN-tyrosine kinases, *CENTRAL nervous system
Abstract

Background: The ALEX study demonstrated significantly improved progression-free survival (PFS) with alectinib versus crizotinib in treatment-naive ALK-positive non-small-cell lung cancer (NSCLC) at the primary data cut-off (9 February 2017). We report mature PFS (cut-off: 30 November 2018) and overall survival (OS) data up to 5 years (cut-off: 29 November 2019). Patients and methods: Patients with stage III/IV ALK-positive NSCLC were randomized to receive twice-daily alectinib 600 mg (n = 152) or crizotinib 250 mg (n = 151) until disease progression, toxicity, withdrawal or death. Primary end point: investigator-assessed PFS. Secondary end points included objective response rate, OS and safety. Results: Mature PFS data showed significantly prolonged investigator-assessed PFS with alectinib [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.32e0.58; median PFS 34.8 versus 10.9 months crizotinib]. Median duration of OS follow-up: 48.2 months alectinib, 23.3 months crizotinib. OS data remain immature (37% of events). Median OS was not reached with alectinib versus 57.4 months with crizotinib (stratified HR 0.67, 95% CI 0.46e0.98). The 5-year OS rate was 62.5% (95% CI 54.3e70.8) with alectinib and 45.5% (95% CI 33.6e57.4) with crizotinib, with 34.9% and 8.6% of patients still on study treatment, respectively. The OS benefit of alectinib was seen in patients with central nervous system metastases at baseline [HR 0.58 (95% CI 0.34e1.00)] and those without [HR 0.76 (95% CI 0.45 e1.26)]. Median treatment duration was longer with alectinib (28.1 versus 10.8 months), and no new safety signals were observed. Conclusions: Mature PFS data from ALEX confirmed significant improvement in PFS for alectinib over crizotinib in ALKpositive NSCLC. OS data remain immature, with a higher 5-year OS rate with alectinib versus crizotinib. This is the first global randomized study to show clinically meaningful improvement in OS for a next-generation tyrosine kinase inhibitor versus crizotinib in treatment-naive ALK-positive NSCLC. [ABSTRACT FROM AUTHOR]

Published
2020
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20. Brigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer.

Author

Camidge, D. R., Kim, H. R., Ahn, M.-J., Yang, J. C.-H., Han, J.-Y., Lee, J.-S., Hochmair, M. J., Li, J. Y.-C., Chang, G.-C., Lee, K. H., Gridelli, C., Delmonte, A., Campelo, R. Garcia, Kim, D.-W., Bearz, A., Griesinger, F., Morabito, A., Felip, E., Califano, R., and Ghosh, S.

Abstract

BACKGROUND Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, has robust efficacy in patients with ALK-positive non-small-cell lung cancer (NSCLC) that is refractory to crizotinib. The efficacy of brigatinib, as compared with crizotinib, in patients with advanced ALK-positive NSCLC who have not previously received an ALK inhibitor is unclear. METHODS In an open-label, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with advanced ALK-positive NSCLC who had not previously received ALK inhibitors to receive brigatinib at a dose of 180 mg once daily (with a 7-day lead-in period at 90 mg) or crizotinib at a dose of 250 mg twice daily. The primary end point was progression-free survival as assessed by blinded independent central review. Secondary end points included the objective response rate and intracranial response. The first interim analysis was planned when approximately 50% of 198 expected events of disease progression or death had occurred. RESULTS A total of 275 patients underwent randomization; 137 were assigned to brigatinib and 138 to crizotinib. At the first interim analysis (99 events), the median followup was 11.0 months in the brigatinib group and 9.3 months in the crizotinib group. The rate of progression-free survival was higher with brigatinib than with crizotinib (estimated 12-month progression-free survival, 67% [95% confidence interval {CI}, 56 to 75] vs. 43% [95% CI, 32 to 53]; hazard ratio for disease progression or death, 0.49 [95% CI, 0.33 to 0.74]; P<0.001 by the log-rank test). The confirmed objective response rate was 71% (95% CI, 62 to 78) with brigatinib and 60% (95% CI, 51 to 68) with crizotinib; the confirmed rate of intracranial response among patients with measurable lesions was 78% (95% CI, 52 to 94) and 29% (95% CI, 11 to 52), respectively. No new safety concerns were noted. CONCLUSIONS Among patients with ALK-positive NSCLC who had not previously received an ALK inhibitor, progression-free survival was significantly longer among patients who received brigatinib than among those who received crizotinib. (Funded by Ariad Pharmaceuticals; ALTA-1L ClinicalTrials.gov number, NCT02737501.). [ABSTRACT FROM AUTHOR]

Published
2018
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21. Efficacy and Safety of Ceritinib in Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Rearranged (ALK plus ) Non-Small Cell Lung Cancer (NSCLC) : An Update of ASCEND-1: Metastatic Non-Small Cell Lung Cancer

Author

Kim, D., Mehra, R., Tan, DSW, Felip, E., Chow, LQM, Camidge, D. R., Vansteenkiste, J., Sharma, S., De Pas, T., Riely, G. J., Solomon, B. J., Wolf, J., Thomas, M., Schuler, Martin, Liu, G., Santoro, A., Geraldes, M., Boral, A. L., Yovine, A., and Shaw, A. T.

Subjects
Medizin
Published
2014

24. Symptomatic reduction in free testosterone levels secondary to crizotinib use in male cancer patients

Author

Weickhardt, Aj, Doebele, Rc, Purcell, Wt, Bunn, Pa, Oton, Ab, Rothman, Ms, Wierman, Me, Mok, T, Popat, S, Bauman, J, Nieva, J, Novello, Silvia, Ou, Sh, and Camidge, D. R.

Subjects
Adult, Aged, 80 and over, Male, Lung Neoplasms, Pyridines, Hypogonadism, Antineoplastic Agents, Luteinizing Hormone, Middle Aged, Article, Crizotinib, Carcinoma, Non-Small-Cell Lung, Sex Hormone-Binding Globulin, Surveys and Questionnaires, Androgens, Humans, Pyrazoles, Testosterone, Follicle Stimulating Hormone, Colorectal Neoplasms, Protein Kinase Inhibitors, Serum Albumin, Aged
Abstract

Crizotinib is a tyrosine kinase inhibitor active against ALK, MET, and ROS1. We previously reported that crizotinib decreases testosterone in male patients. The detailed etiology of the effect, its symptomatic significance, and the effectiveness of subsequent testosterone replacement have not been previously reported.Male cancer patients treated with crizotinib had total testosterone levels measured and results compared with non-crizotinib-treated patients. Albumin, sex hormone-binding globulin (SHBG), follicle-stimulating hormone (FSH), and/or luteinizing hormone (LH) were tracked longitudinally. A subset of patients had free testosterone levels measured and a hypogonadal screening questionnaire administered. Patients receiving subsequent testosterone supplementation were assessed for symptomatic improvement.Mean total testosterone levels were -25% below the lower limit of normal (LLN) in 32 crizotinib-treated patients (27 of 32 patients below LLN, 84%) compared with +29% above LLN in 19 non-crizotinib-treated patients (6 of 19 below LLN, 32%), P = .0012. Levels of albumin and SHBG (which both bind testosterone) declined rapidly with crizotinib, but so did FSH, LH, and free testosterone, suggesting a centrally mediated, true hypogonadal effect. Mean free testosterone levels were -17% below LLN (19 of 25 patients below LLN, 76%). Eighty-four percent (16 of 19) with low free levels, and 79% (19/24) with low total levels had symptoms of androgen deficiency. Five of 9 patients (55%) with low testosterone given testosterone supplementation had improvement in symptoms, coincident with increases in testosterone above LLN.Symptoms of androgen deficiency and free or total/free testosterone levels should be tracked in male patients on crizotinib with consideration of testosterone replacement as appropriate.

Published
2013

26. Abstract 927: Pretreatment and serial plasma assessments of EGFR mutations in NSCLC patients treated with rociletinib (CO-1686)

Author

Goldman, Jonathan W., primary, Karlovich, Chris, additional, Mann, Elaina, additional, Rolfe, Lindsey, additional, Matheny, Shannon, additional, Despain, Darrin, additional, Angenendt, Philipp, additional, Stamm, Claudia, additional, Wakelee, Heather A., additional, Soria, Jean-Charles, additional, Solomon, Benjamin, additional, Camidge, D. R., additional, Dziadziuszko, Rafal, additional, Horn, Leora, additional, Gadgeel, Shirish, additional, Raponi, Mitch, additional, Allen, Andrew R., additional, and Sequist, Lecia V., additional

Published
2015
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30. A phase I dose-escalation and pharmacokinetic study of sunitinib in combination with pemetrexed in patients with advanced solid malignancies, with an expanded cohort in non-small cell lung cancer

Author

Chow, L. Q. M., primary, Blais, N., additional, Jonker, D. J., additional, Laurie, S. A., additional, Diab, S. G., additional, Canil, C., additional, McWilliam, M., additional, Thall, A., additional, Ruiz-Garcia, A., additional, Zhang, K., additional, Tye, L., additional, Chao, R. C., additional, and Camidge, D. R., additional

Published
2011
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32. Progression-free survival (PFS) from a phase I study of crizotinib (PF-02341066) in patients with ALK-positive non-small cell lung cancer (NSCLC).

Author

Camidge, D. R., primary, Bang, Y., additional, Kwak, E. L., additional, Shaw, A. T., additional, Iafrate, A. J., additional, Maki, R. G., additional, Solomon, B. J., additional, Ou, S. I., additional, Salgia, R., additional, Wilner, K. D., additional, Costa, D. B., additional, Shapiro, G., additional, LoRusso, P., additional, Stephenson, P., additional, Tang, Y., additional, Ruffner, K., additional, and Clark, J. W., additional

Published
2011
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33. Initial phase II results with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC): PROFILE 1005.

Author

Crinò, L., primary, Kim, D., additional, Riely, G. J., additional, Janne, P. A., additional, Blackhall, F. H., additional, Camidge, D. R., additional, Hirsh, V., additional, Mok, T., additional, Solomon, B. J., additional, Park, K., additional, Gadgeel, S. M., additional, Martins, R., additional, Han, J., additional, De Pas, T. M., additional, Bottomley, A., additional, Polli, A., additional, Petersen, J., additional, Tassell, V. R., additional, and Shaw, A. T., additional

Published
2011
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34. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) of HGS1029, an inhibitor of apoptosis protein (IAP) inhibitor, in patients (Pts) with advanced solid tumors: Results of a phase I study.

Author

Sikic, B. I., primary, Eckhardt, S. G., additional, Gallant, G., additional, Burris, H. A., additional, Camidge, D. R., additional, Colevas, A. D., additional, Jones, S. F., additional, Messersmith, W. A., additional, Wakelee, H. A., additional, Li, H., additional, Kaminker, P. G., additional, Morris, S., additional, and Infante, J. R., additional

Published
2011
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35. Impact of crizotinib on survival in patients with advanced, ALK-positive NSCLC compared with historical controls.

Author

Shaw, A. T., primary, Yeap, B. Y., additional, Solomon, B. J., additional, Riely, G. J., additional, Iafrate, A. J., additional, Shapiro, G., additional, Costa, D. B., additional, Butaney, M., additional, Ou, S. I., additional, Maki, R. G., additional, Bang, Y., additional, Varella-Garcia, M., additional, Salgia, R., additional, Wilner, K. D., additional, Kulig, K., additional, Selaru, P., additional, Tang, Y., additional, Kwak, E. L., additional, Clark, J. W., additional, and Camidge, D. R., additional

Published
2011
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39. Phase I study evaluating the safety, tolerability, and pharmacokinetics (PK) of HGS1029, a small-molecule inhibitor of apoptosis protein (IAP), in patients (pts) with advanced solid tumors.

Author

Eckhardt, S. G., primary, Gallant, G., additional, Sikic, B. I., additional, Camidge, D. R., additional, Burris, H. A., additional, Wakelee, H. A., additional, Messersmith, W. A., additional, Jones, S. F., additional, Colevas, A. D., additional, and Infante, J. R., additional

Published
2010
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41. A phase II, open-label study of ramucirumab (IMC-1121B), an IgG1 fully human monoclonal antibody (MAb) targeting VEGFR-2, in combination with paclitaxel and carboplatin as first-line therapy in patients (pts) with stage IIIb/IV non-small cell lung cancer (NSCLC).

Author

Camidge, D. R., primary, Ballas, M. S., additional, Dubey, S., additional, Haigentz, M., additional, Rosen, P. J., additional, Spicer, J. F., additional, West, H. J., additional, Shah, G. D., additional, Youssoufian, H., additional, and Mita, A. C., additional

Published
2010
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42. PF-00299804 (PF299) patient (pt)-reported outcomes (PROs) and efficacy in adenocarcinoma (adeno) and nonadeno non-small cell lung cancer (NSCLC): A phase (P) II trial in advanced NSCLC after failure of chemotherapy (CT) and erlotinib (E).

Author

Campbell, A., primary, Reckamp, K. L., additional, Camidge, D. R., additional, Giaccone, G., additional, Gadgeel, S. M., additional, Khuri, F. R., additional, Engelman, J. A., additional, Denis, L. J., additional, O'Connell, J. P., additional, and Janne, P. A., additional

Published
2010
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44. A phase I safety and tolerability study of vorinostat (V) in combination with sorafenib (S) in patients with advanced solid tumors, with exploration of two tumor-type specific expanded cohorts at the recommended phase II dose (renal and non-small cell lung carcinoma).

Author

Dasari, A., primary, Gore, L., additional, Messersmith, W. A., additional, Diab, S., additional, Jimeno, A., additional, Weekes, C. D., additional, Lewis, K. D., additional, Drabkin, H. A., additional, Flaig, T. W., additional, and Camidge, D. R., additional

Published
2010
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