At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Pamiparib (BGB-290) in Cancer Patients
In Brief
A Phase 1 clinical trial evaluating pamiparib 60 mg, pamiparib 20 mg, and 3 other interventions for Solid Tumor. Completed, enrolled 25 participants across 4 sites in 4 countries.
Detailed Summary
The study was an open-label, parallel-group, fixed-sequence study in male and female cancer patients. The study consists of 2 phases: the Core Phase, which is divided into Part A and Part B, and the Extension Phase. Part A investigated the effect of CYP3A induction by rifampin on the single dose pharmacokinetics (PK) of pamiparib, and Part B investigated the effect of CYP3A inhibition by itraconazole on the single dose PK of pamiparib. Participants were offered participation in the Extension Phase, in which they received pamiparib until progression of disease, unacceptable toxicity, withdrawal of consent, or any other reason for discontinuation.
Study Details
Timeline
Interventions
Single dose of 60 mg pamiparib orally on Days 1 and 10
Single dose of 20 mg pamiparib orally on days 1 and 7
200 mg itraconazole once a day al Day 3 to day 8
600 mg rifampin once a day from days 3 to 11
60 mg pamiparib orally twice a day in 28-day cycles