Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Endometrial Adenocarcinoma
- Deleterious BRCA1 Gene Mutation
- Deleterious BRCA2 Gene Mutation
- 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
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of niraparib and copanlisib in patients with recurrent high-grade serous or BRCA mutant ovarian cancer or recurrent endometrial, fallopian tube, or primary peritoneal cancer...
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of niraparib and copanlisib in patients with recurrent high-grade serous or BRCA mutant ovarian cancer or recurrent endometrial, fallopian tube, or primary peritoneal cancer. SECONDARY OBJECTIVES: I. To determine the tolerability of the RP2D of niraparib and copanlisib. II. To determine the safety and observed toxicities of the combination of niraparib and copanlisib in patients with recurrent endometrial, recurrent high-grade serous ovarian, or BRCA mutant ovarian cancer. III. To estimate the activity of the drug combination at all dose levels in each patient cohort by objective response rate and proportion of patients surviving progression free (PFS) at 6 months. IV. To determine response duration of the drug combination at all dose levels. V. To determine the pharmacokinetics (PK) of the combination to assess the presence of any drug interaction between the two co-administered agents. EXPLORATORY OBJECTIVES: I. To determine if response to therapy is associated with molecular profile of the tumor (including, but not limited to, molecular aberrations in the PI3K-AKT-mTOR pathway or defects in homologous recombination) before treatment. II. To examine associations with early changes in functional proteomic biomarkers in tumor biopsies before and after treatment and tumor response in patients with recurrent endometrial, recurrent high-grade serous ovarian, or BRCA mutant ovarian cancer treated with the investigational agents. OUTLINE: This is a dose-escalation study. Patients receive niraparib orally (PO) daily on days 1-28 and copanlisib intravenously (IV) over 1 hour on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 and 90 days, then every 3 months for up to 5 years.
Tracking Information
- NCT #
- NCT03586661
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Shannon N Westin M.D. Anderson Cancer Center