Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
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ClinicalTrials.gov Identifier: NCT03329001 |
Recruitment Status :
Recruiting
First Posted : November 1, 2017
Last Update Posted : April 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neoplasms | Drug: Niraparib Tablet Drug: Niraparib Capsule | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 208 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients With Advanced Solid Tumors |
Actual Study Start Date : | November 29, 2017 |
Estimated Primary Completion Date : | July 16, 2021 |
Estimated Study Completion Date : | December 15, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Stage 1: Tablet-Capsule Sequence
Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase
|
Drug: Niraparib Tablet
Niraparib tablet formulation Drug: Niraparib Capsule Niraparib capsule formulation |
Experimental: Stage 1: Capsule-Tablet Sequence
Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
|
Drug: Niraparib Tablet
Niraparib tablet formulation Drug: Niraparib Capsule Niraparib capsule formulation |
Experimental: Stage 2: Tablet-Capsule Sequence
Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase.
|
Drug: Niraparib Tablet
Niraparib tablet formulation Drug: Niraparib Capsule Niraparib capsule formulation |
Experimental: Stage 2: Capsule-Tablet Sequence
Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
|
Drug: Niraparib Tablet
Niraparib tablet formulation Drug: Niraparib Capsule Niraparib capsule formulation |
Experimental: Stage 3: High fat meal-fasted sequence
Single dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state.
|
Drug: Niraparib Tablet
Niraparib tablet formulation |
Experimental: Stage 3: Fasted-high fat meal sequence
Single dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal.
|
Drug: Niraparib Tablet
Niraparib tablet formulation |
- Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC[0-t]) for niraparib-Stages 1, 2 and 3 PK Phase [ Time Frame: Up to 168 hours post-dose ]
- Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0 to inf]) for niraparib-Stages 1, 2 and 3 PK Phase [ Time Frame: Up to 168 hours post-dose ]
- Maximum observed plasma concentration (Cmax) for niraparib-Stages 1, 2 and 3 PK Phase [ Time Frame: Up to 168 hours post-dose ]
- Time to reach maximum observed plasma concentration (Tmax) for niraparib-Stages 1, 2 and 3 PK Phase [ Time Frame: Up to 168 hours post-dose ]
- Terminal elimination half-life (T1/2) for niraparib-Stages 1, 2 and 3 PK Phase [ Time Frame: Up to 168 hours post-dose ]
- Apparent total body clearance for niraparib-Stages 1, 2 and 3 PK Phase [ Time Frame: Up to 168 hours post-dose ]
- Apparent terminal volume of distribution for niraparib-Stages 1, 2 and 3 PK Phase [ Time Frame: Up to 168 hours post-dose ]
- Time from administration of the dose to the first quantifiable concentration (Tlag) for niraparib-Stage 3 PK Phase [ Time Frame: Up to 168 hours post-dose ]
- Number of participants with treatment emergent adverse events (TEAEs), serious TEAEs and discontinuations due to TEAEs-Stages 1, 2 and 3 PK Phase [ Time Frame: Up to 54 days ]
- Number of participants with TEAEs, serious TEAEs and discontinuations due to TEAEs-Extension Phase [ Time Frame: Approximately 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key inclusion criteria:
PK Phase: To be considered eligible to participate in this study, all of the following requirements must be met:
- Participants with histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumors that have failed to respond to standard therapy, has progressed despite standard therapy, or for which no standard therapy exists, and who may benefit from treatment with a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor as assessed by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate organ function as defined: Absolute neutrophil count ≥ 1,500 per microliter (/μL) (For Stage 3: >=1000/μL); Platelets ≥ 100,000/μL; Hemoglobin ≥ 9 grams per deciliter (g/dL) (5.6 millimolar [mM]); Serum creatinine ≤ 1.5 × the upper limit of normal (ULN) or a calculated creatinine clearance ≥ 60 milliliters per minute (mL/min) using the Cockcroft-Gault equation or 24-hour urine creatinine clearance.; Total bilirubin ≤ 1.5 × ULN except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin ≤ 1.5 × ULN of the direct bilirubin; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN unless liver metastases are present, in which case, they must be ≤ 5 × ULN.
- Participant has recovered to Grade 1 toxicity from prior cancer therapy (a participant with Grade 2 neuropathy or Grade 2 alopecia is an exception to this criterion and may qualify for this study).
- Female participant of childbearing potential is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug.
- Male participant agrees to use an adequate method of contraception and not donate sperm starting with the first dose of study drug through 90 days after the last dose of study drug.
- (For Stage 3): CNS inclusion - Based on screening brain magnetic resonance imaging indicating no evidence of brain metastasis or needing immediate local therapy.
Extension Phase:
- ECOG performance status of 0 to 2.
- Adequate organ function as defined: Absolute neutrophil count ≥ 1,500/μL (For Stage 3: >=1000/μL); Platelets ≥ 100,000/μL; Hemoglobin ≥ 9 g/dL (5.6 mM); serum creatinine ≤ 1.5 × the ULN or a calculated creatinine clearance ≥ 60 mL/min (For Stage 3: ≥ 30 mL/min) using the Cockcroft-Gault equation or 24-hour urine creatinine clearance; Total bilirubin ≤ 1.5 × ULN except in participant with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin ≤ 1.5 × ULN of the direct bilirubin; AST and ALT ≤ 2.5 × ULN unless liver metastases are present, in which case, they must be ≤5 × ULN
- Female participant of childbearing potential is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug.
- Male participant agrees to use an adequate method of contraception and not donate sperm starting with the first dose of study drug through 90 days after the last dose of study drug.
- Participate is able to eat a high fat meal
- Participant is able to fast for a minimum of 10 hours before start of visit and for an additional 4 hours after study visit.
Key Exclusion Criteria: PK Phase:
- Known diagnosis of immunodeficiency
- Symptomatic uncontrolled brain or leptomeningeal metastases.
- Major surgery within 3 weeks of starting the study or participant has not recovered from any effects of any major surgery.
- Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder; nonmalignant systemic disease; or active, uncontrolled infection.
- Known history of myelodysplastic syndrome or acute myeloid leukemia.
- Participant is currently taking any of the following P-glycoprotein (P-gp) inhibitors: amiodarone, azithromycin, captopril, carvedilol, clarithromycin, conivaptan, cyclosporine, diltiazem, dronedarone, erythromycin, felodipine, itraconazole, ketoconazole, lopinavir and ritonavir, quercetin, quinidine, ranolazine, ticagrelor, and verapamil (Does not apply for Extension Phase).
- Participant taking proton pump inhibitors, antacids, or histamine 2 blockers within 48 hours prior to study drug administration (Does not apply for Extension Phase).
- Participant has gastric, gastro-esophageal or esophageal cancer; participant is unable to swallow orally administered medication; or participant has gastrointestinal disorders or significant gastrointestinal resection likely to interfere with the absorption of niraparib.
- Participant has known active hepatic disease
- Participant has a past or current history of chronic alcohol use.
- Participant has significant pleural effusion or ascites that is expected to require drainage during the PK Phase (Does not apply for Extension Phase).
- For Stage 3 only: Participant is currently taking a lipase inhibitor or cholesterol absorption inhibitor, such as orlistat or ezetimibe, respectively. (Does not apply for participation in Extension Phase of this study).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329001
Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
United States, California | |
GSK Investigational Site | Recruiting |
Encinitas, California, United States, 92024 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Alberto Bessudo | |
GSK Investigational Site | Completed |
Fresno, California, United States, 93720 | |
GSK Investigational Site | Recruiting |
San Marcos, California, United States, 92069 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Alberto Bessudo | |
United States, Colorado | |
GSK Investigational Site | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Gerald Falchook | |
United States, Connecticut | |
GSK Investigational Site | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Navid Hafez | |
United States, Florida | |
GSK Investigational Site | Recruiting |
Sarasota, Florida, United States, 34232 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Manish Patel | |
United States, Georgia | |
GSK Investigational Site | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Robert Harvey | |
United States, Michigan | |
GSK Investigational Site | Recruiting |
Grand Rapids, Michigan, United States, 49546 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Manish Sharma | |
United States, Mississippi | |
GSK Investigational Site | Completed |
Jackson, Mississippi, United States, 39213 | |
United States, Ohio | |
GSK Investigational Site | Completed |
Cincinnati, Ohio, United States, 45267 | |
GSK Investigational Site | Completed |
Cleveland, Ohio, United States, 44106 | |
United States, Oklahoma | |
GSK Investigational Site | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Debra L. Richardson | |
United States, Tennessee | |
GSK Investigational Site | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Erika Hamilton | |
United States, Texas | |
GSK Investigational Site | Recruiting |
Dallas, Texas, United States, 75230 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Minal Barve | |
GSK Investigational Site | Completed |
Houston, Texas, United States, 77030 | |
GSK Investigational Site | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Amita Patnaik |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | Tesaro, Inc. |
ClinicalTrials.gov Identifier: | NCT03329001 |
Other Study ID Numbers: |
213362 3000-01-004 ( Other Identifier: Tesaro ) |
First Posted: | November 1, 2017 Key Record Dates |
Last Update Posted: | April 2, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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