Berzosertib + Gemcitabine for Ovarian Cancer
Trial Summary
What is the purpose of this trial?
This randomized phase II trial studies how well ATR kinase inhibitor M6620 (M6620) and gemcitabine hydrochloride work compared to standard treatment with gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement (recurrent). ATR kinase inhibitor M6620 may stop the growth of tumor cells by blocking an enzyme needed for cell growth, and may also help gemcitabine hydrochloride work better. Gemcitabine hydrochloride is a drug used in chemotherapy that works to stop the growth of tumor cells by blocking cells from growing and repairing themselves, causing them to die. It is not yet known whether adding ATR kinase inhibitor M6620 to standard treatment with gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube 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 should avoid medications that strongly affect the CYP3A4 enzyme, as they may interact with the trial drugs. It's important to discuss your current medications with the trial team to ensure safety.
What data supports the effectiveness of the drug combination Berzosertib + Gemcitabine for ovarian cancer?
Gemcitabine has shown consistent activity in treating platinum-resistant ovarian cancer, with remission rates of nearly 20% and a favorable safety profile. It has been effectively combined with other drugs like carboplatin and oxaliplatin in clinical trials, suggesting potential benefits when used in combination therapies for ovarian cancer.12345
Is the combination of Berzosertib and Gemcitabine safe for treating ovarian cancer?
What makes the drug combination of berzosertib and gemcitabine unique for treating ovarian cancer?
Research Team
Panagiotis A Konstantinopoulos
Principal Investigator
Dana-Farber - Harvard Cancer Center LAO
Eligibility Criteria
This trial is for patients with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that's resistant to platinum-based treatment and has recurred. Participants must have measurable disease, resolved prior therapy side effects (except hair loss), good physical health, and adequate organ function. They can't join if they've had certain recent treatments, brain metastases, uncontrolled illnesses, are pregnant/breastfeeding or HIV-positive on antiretrovirals.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive gemcitabine hydrochloride with or without ATR kinase inhibitor M6620 in 21-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Gemcitabine
- M6620
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor