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

NCT03994211 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-10-26

Study results available
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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

Interventions

DRUG

pamiparib 20 mg

Single dose of 20 mg pamiparib orally on days 1 and 7

DRUG

pamiparib 60 mg

Single dose of 60 mg pamiparib orally on Days 1 and 10

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

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2019-10-25
Completion
2021-08-06

Countries

  • Georgia
  • Moldova
  • Poland
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994211 on ClinicalTrials.gov