A Phase 1/2 Trial of SRA737 in Combination With Gemcitabine Plus Cisplatin or Gemcitabine Alone in Subjects With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT02797977|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2016
Last Update Posted : January 3, 2020
The purpose of this clinical study is to establish the safety profile, determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose (RP2D) and schedule of SRA737 in combination with low dose gemcitabine; and to evaluate the efficacy of SRA737 in combination with low dose gemcitabine in prospectively-selected subjects with genetically-defined tumors that have predicted sensitivity to Chk1 inhibition based on factors including: genetic profiling of tumor tissue or ctDNA, HPV status, and germline BRCA1 and BRCA2 gene status. Specific cancer indications that frequently feature these factors will be studied.
Preclinical and clinical data support the hypothesis that active doses of SRA737 may be strongly potentiated by sub-therapeutic doses of gemcitabine, which should lead to clinical efficacy. To test this hypothesis, SRA737 in combination with low dose gemcitabine is being explored in this study.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: SRA737, gemcitabine, cisplatin Drug: SRA737, gemcitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination With Gemcitabine Plus Cisplatin or Gemcitabine Alone in Subjects With Advanced Cancer|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Standard-Dose Triplet Combination
SRA737 will be administered orally on Days 2, 3, 9, and 10 of each 21-day cycle. Subjects will receive a single dose of SRA737 between 4 to 7 days prior to starting the first cycle for PK profiling. Gemcitabine will be administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin will be administered on Day 1 of each 21-day cycle. Subjects can continue taking the study treatment if they are safely receiving clinical benefit and able to follow the requirements of the study.
Drug: SRA737, gemcitabine, cisplatin
Experimental: Low-Dose Gemcitabine Combination
SRA737 will be administered orally on Days 2, 3, 9, 10, 16, and 17 of each 28-day cycle. Subjects will receive a single dose of SRA737 between 4 to 7 days prior to starting the first cycle. Gemcitabine will be administered intravenously on Days 1, 8, and 15 of each 28-day cycle. Subjects can continue taking the study treatment if they are safely receiving clinical benefit and able to follow the requirements of the study.
Drug: SRA737, gemcitabine
- Number of subjects with adverse events as assessed by CTCAE4.03 [ Time Frame: Up to 30 days after last dose of SRA737 ]
- Maximum tolerated dose of SRA737 administered in combination with gemcitabine [ Time Frame: Cycle 1 (28 days) in the Dose Escalation Phase ]
- Recommended Phase 2 dose of SRA737 in combination with gemcitabine. [ Time Frame: Up to 30 days after last dose of SRA737 ]
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): NCT02797977