Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT03586661 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2026-03-11
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.
Conditions
- Deleterious BRCA1 Gene Mutation
- Deleterious BRCA2 Gene Mutation
- Endometrial Adenocarcinoma
- High Grade Ovarian Serous Adenocarcinoma
- Platinum-Resistant Ovarian Carcinoma
- Primary Peritoneal High Grade Serous Adenocarcinoma
- Progressive Disease
- Recurrent Endometrial Carcinoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
Interventions
- DRUG
-
Copanlisib
Given IV
- DRUG
-
Niraparib
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Shannon N Westin · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-29
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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