Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Perito… (NCT03586661) | Clinical Trial Compass
CompletedPhase 1
Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
United States31 participantsStarted 2019-04-29
Plain-language summary
This phase Ib trial studies the best dose and side effects of niraparib and copanlisib in treating patients with endometrial, ovarian, primary peritoneal, or fallopian tube cancer that has come back. Niraparib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any histologically confirmed recurrent endometrial adenocarcinoma (except for carcinosarcoma), recurrent high-grade serous ovarian/primary peritoneal/fallopian tube carcinoma, or deleterious BRCA mutant recurrent ovarian/primary peritoneal/fallopian tube cancer for whom no curative option is available will be eligible. DOSE ESCALATION ONLY: For patients with ovarian cancer in the dose escalation cohort, only patients with recurrent, platinum resistant disease are eligible to enroll on study. Platinum resistance is defined as progression within 6 months from completion of platinum based therapy (the date should be calculated from the last administered dose of platinum therapy). In addition, patients in this cohort with a BRCA mutation must have also progressed after treatment with PARP inhibitor.
* Patients may have unlimited prior chemotherapeutic regimens for management of recurrent endometrial or ovarian carcinoma. Patients who have received prior PARP inhibitors ARE allowed to participate. Patients who have received prior PI3K-pathway inhibitors ARE allowed to participate on the dose escalation phase ONLY. Patients may have progressed on prior PARP inhibitor and/or PI3K-pathway inhibitor but they may not have discontinued drug for toxicity.
* With the exception of alopecia, peripheral neuropathy, and bone marrow parameters, any unresolved toxicities from prior chemotherapy should be no greater than Common Terminology Criteria for Adverse Events (CTCA…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.