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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2021-08-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part A (core phase)

60 mg pamiparib administered orally on Days 1 and 10 fasting 8 hours pre-dose 600 mg rifampin once a day from days 3 to 11 in the fasted state (at least 2 hours predose)

Group Type EXPERIMENTAL

pamiparib 60 mg

Intervention Type DRUG

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

rifampin

Intervention Type DRUG

600 mg rifampin once a day from days 3 to 11

Part B (core phase)

Single dose of 20 mg pamiparib orally in the fasted state (at least 8 hours predose) on days 1 and 7 200 mg itraconazole once a day approximately 30 minutes after completing a meal Day 3 to day 8

Group Type EXPERIMENTAL

pamiparib 20 mg

Intervention Type DRUG

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

itraconazole

Intervention Type DRUG

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

Extension phase

60 mg pamiparib orally twice a day in 28-day cycles until progression of disease

Group Type EXPERIMENTAL

pamiparib

Intervention Type DRUG

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

Interventions

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pamiparib 60 mg

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

Intervention Type DRUG

pamiparib 20 mg

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

Intervention Type DRUG

itraconazole

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

Intervention Type DRUG

rifampin

600 mg rifampin once a day from days 3 to 11

Intervention Type DRUG

pamiparib

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. 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.
3. Disease that is evaluable per RECIST Version 1.1 or Prostate Cancer Working Group-3 (PCWG-3)
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
5. Life expectancy ≥ 12 weeks
6. Adequate hematologic and end-organ function

Exclusion Criteria

1. History of hypersensitivity to rifampin, any rifamycin or any of the components of the rifampin capsule (Part A).
2. History of hypersensitivity to itraconazole or any of the components of the itraconazole capsule (Part B).
3. 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
4. Diagnosis of Myelodysplastic syndrome (MDS)
5. Active infection requiring systemic treatment
6. Any of the following cardiovascular criteria:

1. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before Day 1 of pamiparib administration
2. Symptomatic pulmonary embolism ≤ 28 days before Day 1 of pamiparib administration
3. Any history of acute myocardial infarction ≤ 6 months before Day 1 of pamiparib administration
4. 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)
5. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before Day 1 of pamiparib administration
6. Any history of cerebral vascular accident ≤ 6 months before Day 1 of pamiparib administration
7. 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
8. Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis, or melena ≤ 6 months before Day 1 of pamiparib administration
9. 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
10. Known history of intolerance to the excipients of the pamiparib capsule
11. Have known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No