Skip to main content
OpenTrials
Completed

NCT Number: NCT03994211

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arensia Exploratory Medicine Llc, Tbilisi, Georgia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically or cytologically confirmed advanced or metastatic solid tumors that are refractory or resistant to standard therapy or for which no suitable effective standard therapy exists.
  • Disease that is evaluable per RECIST Version 1.1 or Prostate Cancer Working Group-3 (PCWG-3)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Life expectancy ≥ 12 weeks
  • Adequate hematologic and end-organ function

Key Exclusion Criteria:

  • History of hypersensitivity to rifampin, any rifamycin or any of the components of the rifampin capsule (Part A).
  • History of hypersensitivity to itraconazole or any of the components of the itraconazole capsule (Part B).
  • Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor at therapeutic doses is allowed, provided that such treatment was not the most recent therapy (PARP inhibitor must have been discontinued ≥ 3 months prior to the first dose of pamiparib):
  • Participants who experienced prior severe toxicity to PARP inhibitors that in the opinion of the investigator precludes further treatment with PARP inhibitors should be excluded
  • Diagnosis of Myelodysplastic syndrome (MDS)
  • Active infection requiring systemic treatment
  • Any of the following cardiovascular criteria:
  • Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before Day 1 of pamiparib administration
  • Symptomatic pulmonary embolism ≤ 28 days before Day 1 of pamiparib administration
  • Any history of acute myocardial infarction ≤ 6 months before Day 1 of pamiparib administration
  • Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before Day 1 of pamiparib
  • Participants with congestive heart failure or history of heart failure should be excluded from Part B (itraconazole)
  • Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before Day 1 of pamiparib administration
  • Any history of cerebral vascular accident ≤ 6 months before Day 1 of pamiparib administration
  • Previous complete gastric resection or lap-band surgery, chronic diarrhea, active inflammatory gastrointestinal disease, known diverticular disease or any other disease-causing malabsorption syndrome
  • Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed
  • Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis, or melena ≤ 6 months before Day 1 of pamiparib administration
  • Use or anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers ≤ 14 days (or ≤ 5 half-lives if half-life is known) prior to Day 1 of pamiparib administration
  • Known history of intolerance to the excipients of the pamiparib capsule
  • Have known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

pamiparib 60 mg

Drug

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

pamiparib 20 mg

Drug

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

Itraconazole

Drug

200 mg itraconazole once a day al Day 3 to day 8

Rifampin

Drug

600 mg rifampin once a day from days 3 to 11

Pamiparib

Drug

60 mg pamiparib orally twice a day in 28-day cycles

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part A

    Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose

  2. Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part B

    Time frame: Part B: from Day -1 (admission) to Day 9 (discharge; ) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose

  3. AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part A

    Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose

  4. AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part B

    Time frame: Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose

  5. AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part A

    Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose

  6. AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part B

    Time frame: Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose

  7. AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part A

    Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose

  8. AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part B

    Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose

  9. AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part A

    Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose

  10. AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part B

    Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose

  11. Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part A

    Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

  12. Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part B

    Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

  13. Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part A

    Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

  14. Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part B

    Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

  15. Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part A

    Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

  16. Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part B

    Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

  17. Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part A

    Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

  18. Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part B

    Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: From the date informed consent has been signed until last study medication dose plus 30 days (up to approximately 26 months)

    TEAE is defined as any AE with an onset date on or after the date of first dose of study medication until the date of last study medication dose plus 30 days. Seriousness of the AE is determined by the investigator based on seriousness criteria.

  2. Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments, Vital Signs, ECG Parameters and Physical Examinations

    Time frame: Up to approximately 26 months

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Jun 21, 2019
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.