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Clinical Trial Summary

This phase I trial identifies the best dose, possible benefits and/or side effects of gemcitabine in combination with elimusertib (BAY 1895344) in treating patients with pancreatic, ovarian, and other solid tumors that have spread to other places in the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cell from making DNA and may kill tumor cells. elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and elimusertib in combination may shrink or stabilize cancer.


Clinical Trial 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 combination with elimusertib (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 elimusertib (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 elimusertib orally (PO) once daily (QD) or twice daily (BID) on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial and collection of blood samples during screening and on days 1, 2, and 9-10 of cycle 1. Patients in the dose-expansion portion of the trial also undergo biopsies during screening and on day 9 of cycle 1. After completion of study treatment, patients are followed up for 30 days. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Advanced Fallopian Tube Carcinoma
  • Advanced Malignant Solid Neoplasm
  • Advanced Ovarian Carcinoma
  • Advanced Pancreatic Adenocarcinoma
  • Advanced Primary Peritoneal Carcinoma
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Fallopian Tube Neoplasms
  • Metastatic Pancreatic Adenocarcinoma
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Peritoneal Neoplasms
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Primary Peritoneal High Grade Serous Adenocarcinoma
  • Stage II Pancreatic Cancer AJCC v8
  • Stage III Fallopian Tube Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage III Primary Peritoneal Cancer AJCC v8
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Stage IV Primary Peritoneal Cancer AJCC v8
  • Unresectable Pancreatic Adenocarcinoma

NCT number NCT04616534
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 1
Start date June 1, 2021
Completion date July 1, 2024

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