Clinical Trials Logo
  1. Home
  2. Primary Peritoneal Cancer
  3. NCT01339650

Study of ABT-767 in Subjects With Breast Cancer 1 and Breast Cancer 2 (BRCA 1 and BRCA 2) Mutations and Solid Tumors or High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Primary Peritoneal Cancer Clinical Trial

Official title:
A Phase 1 Study of ABT-767 in BRCA1 or BRCA2 Mutation Carriers With Advanced Solid Tumors and in Subjects With High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Clinical Trial Summary

This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and pharmacodynamics of ABT-767 in subjects with advanced Breast Cancer 1 or 2 gene (BRCA1 or BRCA2)-mutated solid tumors and high grade serous ovarian, fallopian tube, or primary peritoneal cancer.

Clinical Trial Description

This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and pharmacodynamics of ABT-767 in subjects with advanced BRCA1 or BRCA2-mutated solid tumors and high grade serous ovarian, fallopian tube, or primary peritoneal cancer. ABT-767 is a potent oral inhibitor of the enzymes poly (ADP-ribose) polymerase 1 and 2 (PARP-1 and PARP-2). Malignancies with deficiencies in homologous repair, such as BRCA-1 and BRCA-2 deficient tumors, are more dependent on PARP for deoxyribonucleic acid (DNA) repair than normal cells and, thus, are thought to be more sensitive to PARP inhibition. The study design is a single-arm dose escalation study to determine dose-limiting toxicities, maximum tolerated dose and the recommended Phase 2 dose (RPTD) of orally administered ABT-767 in subjects with BRCA mutations and malignancies. In order to further evaluate the safety and tolerability of ABT-767 at the RPTD, 20 additional subjects will be enrolled in an expanded safety cohort consisting of BRCA1- or BRCA2-mutated Breast cancer and Ovarian cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01339650
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 1
Start date May 6, 2011
Completion date November 30, 2017
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03393884 - Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2) Phase 1/Phase 2
Completed NCT04546373 - Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Active, not recruiting NCT05456685 - IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer Phase 2
Recruiting NCT05494580 - Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer Phase 1/Phase 2
Completed NCT02928549 - Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
Completed NCT02480374 - Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer Phase 1
Completed NCT01899599 - PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer Phase 2
Completed NCT01219777 - Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian Phase 1
Completed NCT00959582 - Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143) Phase 1
Terminated NCT00418093 - Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma Phase 2
Completed NCT00314678 - Cisplatin Induction With Paclitaxel Consolidation for Stage III-IV Epithelial Ovarian and Primary Peritoneal Cancer Phase 2
Not yet recruiting NCT04889495 - A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer
Completed NCT01666444 - VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Phase 2
Recruiting NCT05665023 - Bevacizumab Plus Modiifed FOLFIRINOX in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma Phase 2
Terminated NCT01744821 - Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer N/A
Active, not recruiting NCT01220154 - Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer Phase 1
Completed NCT03213964 - Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int Phase 1
Not yet recruiting NCT06063070 - First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer Phase 2
Completed NCT01253681 - Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer Phase 1
Completed NCT01204749 - TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer Phase 3