Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03329001 · ClinicalTrials.gov registry record · Phase 1
Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
A Phase 1 study of Neoplasms, sponsored by Tesaro.
- Completed
- Registry status
- Phase 1
- Development phase
- 236
- Enrollment target
- 16
- Study locations
NCT03329001: Completed Phase 1 study of Neoplasms, sponsored by Tesaro.
NCT03329001 is a Phase 1 study of Neoplasms that has completed, run by Tesaro. The registered enrollment target is 236 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (85% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03329001, a Phase 1 study of Neoplasms, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 236 participants
- Enrollment target
- 16
- Study locations
Study Summary
This is a three stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) and Bioequivalence (BE) of niraparib administered as a tablet formulation compared to the reference capsule formulation currently marketed in the United States. Stage 3 evaluates the effect of a high-fat meal on niraparib pharmacokinetics (PK) following a single dose of the tablet. The Extension Phase of this study is to enable participants enrolled in the study to continue to receive treatment with niraparib tablets if they are tolerating it and, in the Investigator's opinion, may receive benefit.
Primary Outcome
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Conditions Studied
Interventions
- DRUG Niraparib Tablet
- DRUG Niraparib Capsule
Study Locations (16)
Texas
- GSK Investigational Site - Dallas
- GSK Investigational Site - Houston
- GSK Investigational Site - San Antonio
- GSK Investigational Site - San Marcos
California
- GSK Investigational Site - Encinitas
- GSK Investigational Site - Fresno
Ohio
- GSK Investigational Site - Cincinnati
- GSK Investigational Site - Cleveland
Colorado
- GSK Investigational Site - Denver
Connecticut
- GSK Investigational Site - New Haven
Florida
- GSK Investigational Site - Sarasota
Georgia
- GSK Investigational Site - Atlanta
Michigan
- GSK Investigational Site - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2023-06-15 |
| Phase | Phase 1 |
What the finished NCT03329001 record still lists
NCT03329001 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Niraparib Tablet is the first listed.
NCT03329001 lists 16 locations in 11 states (Texas, California, Ohio).
Frequently Asked Questions
What is clinical trial NCT03329001 about?
NCT03329001 is a clinical study titled "Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule". This is a three stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) and Bioequivalence (BE) of niraparib administered as a tablet formulation compared to the reference capsule formulation currently marketed in the United States. Stage ...
What is the current status of trial NCT03329001?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 236 participants. The study started on 2017-12-04. Estimated completion is 2023-06-15.
What conditions does trial NCT03329001 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT03329001?
The interventions under investigation include: Niraparib Tablet (DRUG), Niraparib Capsule (DRUG).
Who is sponsoring clinical trial NCT03329001?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03329001 being conducted?
This trial has 16 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03329001's enrollment target sits among peer trials
236 42nd of 158 higher than 117 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
RECRUITING · Phase 1
-
A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101)
RECRUITING · Phase 1
-
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
RECRUITING · Phase 1
-
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
RECRUITING · Phase 1
-
Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04995341 · 236 participants · NA
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
- NCT05822362 · 236 participants · Phase 2
CBD for Individuals at Risk for Alzheimer's Disease
- NCT06200103 · 236 participants · Phase 2
Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
- NCT06494072 · 236 participants · Phase 4
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI