Testing the Addition of an Anti-cancer Drug, BAY 1895344 ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 54
Summary
- Conditions
- Advanced Fallopian Tube Carcinoma
- Advanced Malignant Solid Neoplasm
- Advanced Ovarian Carcinoma
- Primary Peritoneal High Grade Serous Adenocarcinoma
- Stage IIIC Fallopian Tube Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage IIIB Fallopian Tube Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage III Fallopian Tube Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Advanced Pancreatic Adenocarcinoma
- Stage IIIA Fallopian Tube Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- Stage IIIA1 Fallopian Tube Cancer AJCC v8
- Stage IVA Fallopian Tube Cancer AJCC v8
- Advanced Primary Peritoneal Carcinoma
- Stage IIIA1 Ovarian Cancer AJCC v8
- Stage IIIA2 Fallopian Tube Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Stage IIIC Primary Peritoneal Cancer AJCC v8
- Stage IIIA Primary Peritoneal Cancer AJCC v8
- High Grade Fallopian Tube Serous Adenocarcinoma
- Stage IIIB Primary Peritoneal Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- High Grade Ovarian Serous Adenocarcinoma
- Metastatic Pancreatic Adenocarcinoma
- Stage II Pancreatic Cancer AJCC v8
- Platinum-Resistant Fallopian Tube Carcinoma
- Stage IVB Primary Peritoneal Cancer AJCC v8
- Unresectable Pancreatic Adenocarcinoma
- Stage IIB Pancreatic Cancer AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IIA Pancreatic Cancer AJCC v8
- Platinum-Resistant Ovarian Carcinoma
- Platinum-Resistant Primary Peritoneal Carcinoma
- Stage III Primary Peritoneal Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of gemcitabine in combination with elimusertib (BAY 1895344), as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. (Dose Escalation and Expansion Cohort) II. Determine the maximum tolerated dose (MTD) of gemcitabine in...
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of gemcitabine in combination with elimusertib (BAY 1895344), as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. (Dose Escalation and Expansion Cohort) II. Determine the maximum tolerated dose (MTD) of gemcitabine in combination with BAY 1895344. (Dose Escalation Cohort) SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. Analyze the pharmacokinetic (PK) profile of the gemcitabine and BAY 1895344 combination. III. Assessing whether immunohistochemical markers of deoxyribonucleic acid (DNA) damage, gamma-H2AX and phosphorylated (p)NBS1, increase in on-treatment biopsies compared to the levels seen in pre-treatment biopsies. EXPLORATORY OBJECTIVES: I. Explore biomarkers that predict response to this combination. II. Evaluate mechanisms of acquired resistance to this combination. OUTLINE: This is a dose-escalation study of gemcitabine followed by a dose expansion study. Patients receive gemcitabine intravenously (IV) over 30 minutes on days 1 and 8 and BAY 1895344 orally (PO) twice daily (BID) on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Tracking Information
- NCT #
- NCT04616534
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: James M Cleary Dana-Farber - Harvard Cancer Center LAO
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