Clinical trial · Interventional
Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer
NCT02476552CI-TRIAL-00042736completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Niraparib Oral and IV
- description
- Single Oral dose of Niraparib capsules (unlabeled active pharmaceutical ingredient) orally and a 15-minute IV infusion of Niraparib (labeled active pharmaceutical ingredient)
- interventionNames
- Drug: Niraparib IV (Labeled)
- Drug: Niraparib Oral Capsules (Unlabeled)
- type
- EXPERIMENTAL
- label
- Niraparib Oral
- description
- Single Oral dose of Niraparib capsules (labeled active pharmaceutical ingredient)
- interventionNames
- Drug: Niraparib Oral Capsules (Labeled)
Primary outcomes (1)
- measure
- Oral bioavailability (F) will be derived using F=AUCoral / AUCiv as a %
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.