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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma, Ovarian Epithelial
  • Fallopian Tube Neoplasms
  • Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Ovarian Mass
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Primary Peritoneal Serous Adenocarcinoma
  • Stage III Fallopian Tube Cancer AJCC v7
  • Stage III Ovarian Cancer AJCC v6 and v7
  • Stage III Primary Peritoneal Cancer AJCC v7
  • Stage IIIA Fallopian Tube Cancer AJCC v7
  • Stage IIIA Ovarian Cancer AJCC v6 and v7
  • Stage IIIA Primary Peritoneal Cancer AJCC v7
  • Stage IIIB Fallopian Tube Cancer AJCC v7
  • Stage IIIB Ovarian Cancer AJCC v6 and v7
  • Stage IIIB Primary Peritoneal Cancer AJCC v7
  • Stage IIIC Fallopian Tube Cancer AJCC v7
  • Stage IIIC Ovarian Cancer AJCC v6 and v7
  • Stage IIIC Primary Peritoneal Cancer AJCC v7
  • Stage IV Fallopian Tube Cancer AJCC v6 and v7
  • Stage IV Ovarian Cancer AJCC v6 and v7
  • Stage IV Primary Peritoneal Cancer AJCC v7

NCT number NCT02316834
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Early Phase 1
Start date June 2, 2015
Completion date January 14, 2022

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