Trials / Completed

CompletedNCT02316834

Talazoparib in Determining Genetic Effects on Disease Response in Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

POSITION: A Pilot Study of Induction PARP Inhibition in Ovarian Cancer

Status: Completed
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 4 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This pilot early phase I trial studies talazoparib to determine if certain characteristics of the deoxyribonucleic acid (DNA) affect how the disease responds to therapy in patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Studying samples of tissue in the laboratory from patients receiving talazoparib may help doctors learn more about the effects of talazoparib on cells and may help doctors understand how well patients respond to treatment.

Detailed description

PRIMARY OBJECTIVES: I. To explore basal levels and effects of talazoparib (BMN 673) on DNA copy number, loss of heterozygosity and mutation, and level of ribonucleic acid (RNA) and protein expression (together described as "molecular results") in homologous recombination-related pathways before and after treatment in women with primary advanced high grade serous ovarian, fallopian tube, or primary peritoneal cancer. SECONDARY OBJECTIVES: I. To correlate molecular results to clinical endpoints including response and survival. II. To correlate molecular results to pathologic endpoints including tumor volume and apoptosis. III. To compare DNA copy number and level of RNA and protein expression in homologous recombination-related pathways in tissue from patients treated with BMN 673 to those untreated with BMN 673 in the preoperative period. IV. To determine the toxicity of daily BMN 673 given preoperatively, with a focus on postoperative wound healing. V. To determine feasibility of daily BMN 673 given preoperatively. OUTLINE: Patients receive talazoparib orally (PO) once daily (QD) for up to 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

Conditions

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	BMN 673	BMN673 given at a dose of 1 mg orally once daily. Participants begin taking BMN 673 tablets by mouth every day, starting on the day of scheduled laparoscopy. Participants take the study drug for at least 7 days before scheduled tumor reduction surgery.

Timeline

Start date: 2015-06-02
Primary completion: 2022-01-14
Completion: 2022-01-14
First posted: 2014-12-15
Last updated: 2022-02-24

Locations

6 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02316834. Inclusion in this directory is not an endorsement.