NCT03994211

Study to Investigate the Effect of Rifampin and Itraconazole on the Action of Pamiparib in Participants With Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	pamiparib 60 mg	Single dose of 60 mg pamiparib orally on Days 1 and 10
DRUG	pamiparib 20 mg	Single dose of 20 mg pamiparib orally on days 1 and 7
DRUG	itraconazole	200 mg itraconazole once a day al Day 3 to day 8
DRUG	rifampin	600 mg rifampin once a day from days 3 to 11
DRUG	pamiparib	60 mg pamiparib orally twice a day in 28-day cycles

Timeline

• Start date: 2019-05-29
• Primary completion: 2019-10-25
• Completion: 2021-08-06
• First posted: 2019-06-21
• Last updated: 2024-10-26
• Results posted: 2023-05-23

Locations

4 sites across 4 countries: Georgia, Moldova, Poland, Slovakia