Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

  • STATUS
    Recruiting
  • participants needed
    44
  • sponsor
    M.D. Anderson Cancer Center
Updated on 5 February 2023
cancer
ascites
hysterectomy
ejection fraction
measurable disease
carcinoma
lipase
oophorectomy
pleural effusion
maintenance therapy
international normalized ratio
prothrombin
replacement therapy
neutrophil count
tumor cells
follicle stimulating hormone
thromboplastin
neuropathy
adenocarcinoma
alopecia
parp inhibitor
ovarian cancer
fallopian tube
niraparib
endometrial adenocarcinoma recurrent
ovarian carcinoma

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.

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.

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.

Details
Condition 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
Treatment Niraparib, Copanlisib
Clinical Study IdentifierNCT03586661
SponsorM.D. Anderson Cancer Center
Last Modified on5 February 2023

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