Elimusertib + Chemotherapy for Pancreatic and Ovarian Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot receive chemotherapy, targeted therapy, or immunotherapy within 3 weeks of starting the trial, and you cannot take certain medications that interact with the trial drugs. It's best to discuss your current medications with the trial team to ensure they don't interfere with the study.
What data supports the effectiveness of the drug Elimusertib + Chemotherapy for Pancreatic and Ovarian Cancer?
Is the combination of Elimusertib and chemotherapy safe for humans?
Gemcitabine, a part of the chemotherapy regimen, has been studied in various combinations for pancreatic and ovarian cancer, showing acceptable safety and tolerability in humans. These studies suggest that gemcitabine can be safely used with other drugs, although specific safety data for Elimusertib is not provided.36789
What makes the drug Elimusertib + Chemotherapy unique for treating pancreatic and ovarian cancer?
Elimusertib combined with chemotherapy, including gemcitabine, is unique because it potentially offers a novel approach by targeting specific cancer pathways, which may enhance the effectiveness of standard chemotherapy. This combination could provide a new option for patients with pancreatic and ovarian cancer, where traditional treatments have limited success.23101112
Research Team
James M Cleary
Principal Investigator
Dana-Farber - Harvard Cancer Center LAO
Eligibility Criteria
Adults with advanced pancreatic, ovarian, or other solid tumors that have spread and are not curable by standard treatments. Participants must have measurable disease, may have had prior gemcitabine treatment, and should not exceed two lines of cytotoxic chemotherapy. HIV-positive patients on effective therapy can join. Women of childbearing potential and men must use contraception during the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Evaluate the safety and tolerability of gemcitabine in combination with elimusertib and determine the maximum tolerated dose
Dose Expansion
Patients receive gemcitabine and elimusertib with additional biopsies and imaging scans to assess response
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BAY 1895344
- Biopsy
- Gemcitabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor