Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer

NCT ID: NCT02476552

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-01-31

Brief Summary

This is an open-label study with 2 parts, plus an extension study following completion of Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6 subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and absolute bioavailability of niraparib.

Detailed Description

Part 1: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib (unlabeled active pharmaceutical ingredient) on Day 1. Two hours after the oral dose, subjects will receive a 15-minute IV infusion of niraparib (labeled pharmaceutical ingredient).

Part 2: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib, labeled active pharmaceutical ingredient.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Niraparib Oral and IV

Single Oral dose of Niraparib capsules (unlabeled active pharmaceutical ingredient) orally and a 15-minute IV infusion of Niraparib (labeled active pharmaceutical ingredient)

Group Type: EXPERIMENTAL

Niraparib IV (Labeled)

Intervention Type: DRUG

Intravenous (IV) infusion of 100 μg niraparib (containing approximately 1 μCi of \[14C\]-niraparib)

Niraparib Oral Capsules (Unlabeled)

Intervention Type: DRUG

Single 300 mg dose of niraparib (unlabeled active pharmaceutical ingredient)

Niraparib Oral

Single Oral dose of Niraparib capsules (labeled active pharmaceutical ingredient)

Group Type: EXPERIMENTAL

Niraparib Oral Capsules (Labeled)

Intervention Type: DRUG

Single 300 mg dose of niraparib

Interventions

Niraparib Oral Capsules (Labeled)

Single 300 mg dose of niraparib

Intervention Type: DRUG

Niraparib IV (Labeled)

Intravenous (IV) infusion of 100 μg niraparib (containing approximately 1 μCi of \[14C\]-niraparib)

Intervention Type: DRUG

Niraparib Oral Capsules (Unlabeled)

Single 300 mg dose of niraparib (unlabeled active pharmaceutical ingredient)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject, male or female, is at least 18 years of age.
• Subject has histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumors that have failed to respond to standard therapy, have progressed despite standard therapy, refuse standard therapy, or for which no standard therapy exists, and that may benefit from treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor. The diagnosis must be confirmed with a previous computed tomography (CT) scan.
• The subject has adequate organ function:
• Subject must have an ECOG performance status of 0 to 2.
• Female subjects of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) within 72 hours prior to receiving the first dose of study drug.

Exclusion Criteria

• Subject has undergone palliative radiotherapy within 1 week of study drug administration, encompassing >20% of the bone marrow.
• Subject has persistent >Grade 2 toxicity from prior cancer therapy.
• Subject has known hypersensitivity to the components of niraparib.
• Subject has had major surgery within 3 weeks of study drug administration or has not recovered from all effects of any major surgery.
• Subject is considered a medical risk due to a serious, uncontrolled medical disorder; nonmalignant systemic disease; or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days of the Screening Visit) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
• Subject has participated in a radioactive clinical study and has received an investigational radiolabeled drug within 6 months prior to study drug administration (for subjects participating in Part 2)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tesaro, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shefali Agarwal, MD

Role: STUDY_DIRECTOR

Tesaro, Inc.

Locations

The Netherlands Cancer Institute

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

PR-30-5015-C

Identifier Type: -

Identifier Source: org_study_id