M6620 + Irinotecan for Cancer
Trial Summary
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). M6620 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it advises avoiding certain drugs that interact with the trial medications. You should discuss your current medications with the study team to ensure there are no interactions.
What data supports the effectiveness of the drug M6620 + Irinotecan for cancer?
What safety information is available for the combination of M6620 and Irinotecan in cancer treatment?
Irinotecan, one of the drugs in this combination, has been associated with side effects like diarrhea and myelosuppression (a decrease in bone marrow activity leading to fewer blood cells). The maximum tolerated dose varies based on genetic factors, and dose-limiting toxicities include neutropenia (low white blood cell count) and diarrhea.678910
What makes the drug M6620 + Irinotecan unique for cancer treatment?
Research Team
Liza C. Villaruz
Principal Investigator
University of Pittsburgh Cancer Institute LAO
Eligibility Criteria
Adults with metastatic or inoperable solid tumors, including pancreatic, colorectal, and small cell lung cancer. Participants must have certain organ functions within normal limits and a life expectancy over 12 weeks. They should be willing to use contraception and undergo mandatory biopsies if in the expansion cohort.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive irinotecan hydrochloride IV over 90 minutes and M6620 IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 12 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Berzosertib
- Irinotecan Hydrochloride
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor