Overview

This trial is active, not recruiting.

Condition cancer
Treatments niraparib oral capsules (labeled), niraparib iv (labeled), niraparib oral capsules (unlabeled)
Phase phase 1
Sponsor Tesaro, Inc.
Start date February 2015
End date December 2015
Trial size 12 participants
Trial identifier NCT02476552, PR-30-5015-C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification bio-availability study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single Oral dose of Niraparib capsules (unlabeled active pharmaceutical ingredient) orally and a 15-minute IV infusion of Niraparib (labeled active pharmaceutical ingredient)
niraparib iv (labeled)
Intravenous (IV) infusion of 100 μg niraparib (containing approximately 1 μCi of [14C]-niraparib)
niraparib oral capsules (unlabeled)
Single 300 mg dose of niraparib (unlabeled active pharmaceutical ingredient)
(Experimental)
Single Oral dose of Niraparib capsules (labeled active pharmaceutical ingredient)
niraparib oral capsules (labeled)
Single 300 mg dose of niraparib

Primary Outcomes

Measure
Oral bioavailability (F) will be derived using F=AUCoral / AUCiv as a %
time frame: 0 - 22 days

Secondary Outcomes

Measure
AUC0-last
time frame: 0 - 22 days
Cmax
time frame: 0 - 22 days

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Tesaro, Inc..