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

NCT02476552 | Completed Phase 1

• 1 other identifier: PR-30-5015-C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Oral bioavailability (F) will be derived using F=AUCoral / AUCiv as a %

  Absolute bioavailability of niraparib will be calculated as the ratio of dose normalized oral to IV niraparib exposure

  0 - 22 days

Secondary Outcomes (2)

• AUC0-last

  0 - 22 days

• Cmax

  0 - 22 days

Study Arms (2)

Niraparib Oral and IV

EXPERIMENTAL

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

Drug: Niraparib IV (Labeled); Drug: Niraparib Oral Capsules (Unlabeled)

Niraparib Oral

EXPERIMENTAL

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

Drug: Niraparib Oral Capsules (Labeled)

Interventions

Niraparib Oral Capsules (Labeled) DRUG

Single 300 mg dose of niraparib

Niraparib Oral

Niraparib IV (Labeled) DRUG

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

Niraparib Oral and IV

Niraparib Oral Capsules (Unlabeled) DRUG

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

Niraparib Oral and IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tesaro, Inc.: lead

Study Sites (1)

The Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Interventions

niraparib; Product Labeling

Intervention Hierarchy (Ancestors)

Product Packaging; Industry; Technology, Industry, and Agriculture

Study Officials

• Shefali Agarwal, MD

  Tesaro, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 19, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2018
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

NL (1)