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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Pharmacokinetic profile
Blood samples for pharmacokinetics of ABT-767 will be collected at designated time points
Various time points from Cycle 1 Day -4 to Day 8
No
Stacie Shepherd, MD
Study Director
AbbVie
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
M10-976
NCT01339650
May 2011
September 2014
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