Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs
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|ClinicalTrials.gov Identifier: NCT03896503|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bladder Small Cell Neuroendocrine Carcinoma Extensive Stage Lung Small Cell Carcinoma Extrapulmonary Small Cell Neuroendocrine Carcinoma Limited Stage Lung Small Cell Carcinoma Platinum-Resistant Lung Small Cell Carcinoma Platinum-Sensitive Lung Small Cell Carcinoma Prostate Small Cell Neuroendocrine Carcinoma Recurrent Lung Small Cell Carcinoma||Drug: Berzosertib Drug: Topotecan Hydrochloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Trial of Topotecan Plus M6620 (VX-970) vs. Topotecan Alone in Patients With Relapsed Small-Cell Lung Cancer|
|Actual Study Start Date :||August 23, 2019|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||September 1, 2023|
Active Comparator: Arm I (topotecan hydrochloride )
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II at disease progression.
Drug: Topotecan Hydrochloride
Experimental: Arm II (topotecan hydrochloride, M6620)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and M6620 IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Topotecan Hydrochloride
- Progression-free survival (PFS) [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last patient has enrolled ]The combination of M6620 with topotecan will be compared to topotecan alone in patients with relapsed small cell lung cancer (SCLC). Kaplan-Meier curves and a one-tailed log-rank test will be the primary analysis methods.
- Objective response rate (ORR) [ Time Frame: Up to 2 years ]
- Overall survival (OS) [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896503
|Principal Investigator:||Anish Thomas||National Cancer Institute LAO|