NeoplasmsPhase 1NCT03329001

Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule

A Phase 1 study testing Niraparib Tablet and Niraparib Capsule in people with Neoplasms, run by Tesaro, Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: Niraparib Tablet and Niraparib Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 236 participants
Where: 16 sitesUnited States
Study dates: 4 Dec 2017to 15 Jun 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.
Participant 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.
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.

Who cannot join

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).

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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).

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

GSK Investigational Site
Atlanta, Georgia, 30322
GSK Investigational Site
Cincinnati, Ohio, 45267
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Denver, Colorado, 80218
GSK Investigational Site
Encinitas, California, 92024
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Grand Rapids, Michigan, 49546
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Jackson, Mississippi, 39216
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
New Haven, Connecticut, 06520
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Marcos, Texas, 92069
GSK Investigational Site
Sarasota, Florida, 34232

Other trials in United States

About this study

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

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.

Conditions: Neoplasms
Being tested: Niraparib Tablet, Niraparib Capsule
Keywords: PARP inhibitor, niraparib, Solid Tumor, Zejula
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Niraparib TabletDrug
Niraparib tablet formulation
Niraparib CapsuleDrug
Niraparib capsule formulation

Study groups in NCT03329001
Study group	Role	What they receive
Stage 1: Tablet-Capsule Sequence	Experimental	Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase Receives: Drug: Niraparib Tablet; Drug: Niraparib Capsule
Stage 1: Capsule-Tablet Sequence	Experimental	Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase Receives: Drug: Niraparib Tablet; Drug: Niraparib Capsule
Stage 2: Tablet-Capsule Sequence	Experimental	Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase. Receives: Drug: Niraparib Tablet; Drug: Niraparib Capsule
Stage 2: Capsule-Tablet Sequence	Experimental	Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase Receives: Drug: Niraparib Tablet; Drug: Niraparib Capsule
Stage 3: High fat meal-fasted sequence	Experimental	Single dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state. Receives: Drug: Niraparib Tablet
Stage 3: Fasted-high fat meal sequence	Experimental	Single dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal. Receives: Drug: Niraparib Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0 to Inf]) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Maximum Observed Plasma Concentration (Cmax) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Terminal Half-life (T1/2) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Apparent Total Body Clearance (CL/F) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Apparent Terminal Volume of Distribution (Vz/F) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0-t) for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0 to Inf) for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Cmax for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Tmax for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
T1/2 for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
CL/F for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Vz/F for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0-t) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0 to Inf) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Cmax for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Tmax for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
T1/2 for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
CL/F for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Vz/F for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Time From Administration of the Dose to the First Quantifiable Concentration (Tlag) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of tlag. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Measured: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period

Secondary outcomes (8)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs-Stage 1 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Measured: Up to 16 days
Number of Participants With TEAEs Leading to Discontinuation -Stage 1 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Measured: Up to 16 days
Number of Participants With TEAEs and Serious TEAEs-Stage 2 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Measured: Up to 24 days
Number of Participants With TEAEs-leading to Discontinuation Stage 2 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Measured: Up to 24 days
Number of Participants With TEAEs and Serious TEAEs-Stage 3 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Measured: Up to 45 days
Number of Participants With TEAEs-leading to Discontinuation Stage 3 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Measured: Up to 45 days
Number of Participants With TEAEs and Serious TEAEs - Extension Phase
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. A summary of number of participants with any TEAEs and serious TEAEs is presented. Serious TEAEs are subset of TEAEs. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Measured: Up to approximately 5 years 5 months
Number of Participants With TEAEs-leading to Discontinuation - Extension Phase
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. A summary of number of participants who discontinued due to any TEAEs is presented. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Measured: Up to approximately 5 years 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 201715 Jun 2023

First posted1 Nov 2017
Study start4 Dec 2017
Primary completion30 Dec 2021
Study completion15 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03329001
Sponsor's protocol ID: 213362
Other IDs: 3000-01-004
Status last verified: Jul 2024
First submitted: 23 Oct 2017
Last updated: 25 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Publications

Falchook G, Patnaik A, Richardson DL, Harvey RD, Sharma MR, Hafez N, Hamilton E, Piha-Paul SA, Barve M, Wise-Draper T, Patel MR, Dowlati A, Pascuzzo J, Tang SC, Faltermeier C, Malinowska IA, Shtessel L, Striha A, Potocka E. A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors. Clin Ther. 2024 Mar;46(3):228-238. doi: 10.1016/j.clinthera.2024.01.004. Epub 2024 Feb 28.
PubMed 38423866

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03329001
Acronym / sponsor ID: 213362
Conditions: Neoplasms
Keywords: PARP inhibitor, niraparib, Solid Tumor, Zejula
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: Tesaro, Inc.Industry (pharma, biotech, devices)
Study start: 4 Dec 2017 (actual)
Primary completion: 30 Dec 2021 (actual)
Study completion: 15 Jun 2023 (actual)
First posted: 1 Nov 2017 (actual)
Results: Posted 26 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Stage 1: Tablet-Capsule Sequence	Experimental	Drug: Niraparib Tablet, Drug: Niraparib CapsuleSingle dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase
Stage 1: Capsule-Tablet Sequence	Experimental	Drug: Niraparib Tablet, Drug: Niraparib CapsuleSingle dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
Stage 2: Tablet-Capsule Sequence	Experimental	Drug: Niraparib Tablet, Drug: Niraparib CapsuleSingle dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase.
Stage 2: Capsule-Tablet Sequence	Experimental	Drug: Niraparib Tablet, Drug: Niraparib CapsuleSingle dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
Stage 3: High fat meal-fasted sequence	Experimental	Drug: Niraparib TabletSingle dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state.
Stage 3: Fasted-high fat meal sequence	Experimental	Drug: Niraparib TabletSingle dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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).

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Niraparib TabletNiraparib tablet formulation	Drug	Stage 1: Capsule-Tablet Sequence, Stage 1: Tablet-Capsule Sequence, Stage 2: Capsule-Tablet Sequence, Stage 2: Tablet-Capsule Sequence, Stage 3: Fasted-high fat meal sequence, Stage 3: High fat meal-fasted sequence
Niraparib CapsuleNiraparib capsule formulation	Drug	Stage 1: Capsule-Tablet Sequence, Stage 1: Tablet-Capsule Sequence, Stage 2: Capsule-Tablet Sequence, Stage 2: Tablet-Capsule Sequence

Primary outcome

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0 to Inf]) for Niraparib-Stage 1 PK Phase
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Maximum Observed Plasma Concentration (Cmax) for Niraparib-Stage 1 PK Phase
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Niraparib-Stage 1 PK Phase
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Terminal Half-life (T1/2) for Niraparib-Stage 1 PK Phase
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Apparent Total Body Clearance (CL/F) for Niraparib-Stage 1 PK Phase
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Apparent Terminal Volume of Distribution (Vz/F) for Niraparib-Stage 1 PK Phase
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
AUC(0-t) for Niraparib-Stage 2 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
AUC(0 to Inf) for Niraparib-Stage 2 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Cmax for Niraparib-Stage 2 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Tmax for Niraparib-Stage 2 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
T1/2 for Niraparib-Stage 2 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
CL/F for Niraparib-Stage 2 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Vz/F for Niraparib-Stage 2 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
AUC(0-t) for Niraparib-Stage 3 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
AUC(0 to Inf) for Niraparib-Stage 3 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Cmax for Niraparib-Stage 3 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Tmax for Niraparib-Stage 3 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
T1/2 for Niraparib-Stage 3 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
CL/F for Niraparib-Stage 3 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Vz/F for Niraparib-Stage 3 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time From Administration of the Dose to the First Quantifiable Concentration (Tlag) for Niraparib-Stage 3 PK Phase
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic assessment of tlag. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.

8 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs-Stage 1 PK Phase (Periods 1 and 2 Only)
Time frame: Up to 16 days
Number of Participants With TEAEs Leading to Discontinuation -Stage 1 PK Phase (Periods 1 and 2 Only)
Time frame: Up to 16 days
Number of Participants With TEAEs and Serious TEAEs-Stage 2 PK Phase (Periods 1 and 2 Only)
Time frame: Up to 24 days
Number of Participants With TEAEs-leading to Discontinuation Stage 2 PK Phase (Periods 1 and 2 Only)
Time frame: Up to 24 days
Number of Participants With TEAEs and Serious TEAEs-Stage 3 PK Phase (Periods 1 and 2 Only)
Time frame: Up to 45 days
Number of Participants With TEAEs-leading to Discontinuation Stage 3 PK Phase (Periods 1 and 2 Only)
Time frame: Up to 45 days
Number of Participants With TEAEs and Serious TEAEs - Extension Phase
Time frame: Up to approximately 5 years 5 months
Number of Participants With TEAEs-leading to Discontinuation - Extension Phase
Time frame: Up to approximately 5 years 5 months

Results and safety

Results posted to the registry on 26 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1: Niraparib Tablet/Capsule	15	15
Stage 1: Niraparib Capsule/Tablet	14	14
Stage 2: Niraparib Tablet/Capsule	0	0
Stage 2: Niraparib Capsule/Tablet	0	0
Stage 3: Niraparib Tablet Fasted/Fed	0	0
Stage 3: Niraparib Tablet Fed/Fasted	0	0
Extension Phase: Niraparib Tablet	0	0
Extension Phase: Niraparib Capsule	0	0

Primary outcome: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: Hours*nanogram per milliliter

Measure	Stage 1: Niraparib Tablet n = 23	Stage 1: Niraparib Capsule n = 23
Value	14900 (43.0)	16100 (41.3)

Stage 1: Niraparib Tablet vs Stage 1: Niraparib Capsule: Ratio of geometric least square mean: 0.9110 (90% CI 0.8550 to 0.9706)

Population analysed: Bioavailability (BA) Evaluable Population included all participants who completed both PK Periods and had sufficient PK sample collection to accurately estimate PK parameters, without significant niraparib carryover (Baseline concentration \>5 percent (%) of maximum observed plasma concentration \[Cmax\]), in both Periods.

Primary outcome: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0 to Inf]) for Niraparib-Stage 1 PK Phase

Measure	Stage 1: Niraparib Tablet n = 23	Stage 1: Niraparib Capsule n = 23
Value	16200 (44.5)	17200 (41.8)

Stage 1: Niraparib Tablet vs Stage 1: Niraparib Capsule: Ratio of geometric least square mean: 0.9216 (90% CI 0.8631 to 0.9841)

Population analysed: BA Evaluable Population

Primary outcome: Maximum Observed Plasma Concentration (Cmax) for Niraparib-Stage 1 PK Phase

Measure	Stage 1: Niraparib Tablet n = 23	Stage 1: Niraparib Capsule n = 23
Value	451 (47.8)	467 (50.0)

Stage 1: Niraparib Tablet vs Stage 1: Niraparib Capsule: Ratio of geometric least square mean: 0.9483 (90% CI 0.8489 to 1.0593)

Population analysed: BA Evaluable Population

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax) for Niraparib-Stage 1 PK Phase

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period. Median (Full Range). Unit: Hours

Measure	Stage 1: Niraparib Tablet n = 23	Stage 1: Niraparib Capsule n = 23
Value	4.05 (1.98 to 8.00)	4.00 (1.52 to 25.02)

Population analysed: BA Evaluable Population

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1: Niraparib Tablet	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29
Stage 1: Niraparib Capsule	0 of 29 (0%)	7 of 29 (24.1%)	0 of 29
Stage 2: Niraparib Tablet	10 of 156 (6.4%)	49 of 156 (31.4%)	2 of 156
Stage 2: Niraparib Capsule	10 of 152 (6.6%)	37 of 152 (24.3%)	5 of 152
Stage 3: Niraparib Tablet Fasted	4 of 26 (15.4%)	6 of 26 (23.1%)	2 of 26
Stage 3: Niraparib Tablet Fed	2 of 25 (8%)	5 of 25 (20%)	0 of 25
Extension Phase: Niraparib Tablet	40 of 124 (32.3%)	113 of 124 (91.1%)	15 of 124
Extension Phase: Niraparib Capsule	20 of 66 (30.3%)	64 of 66 (97%)	3 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38423866Falchook G, Patnaik A, Richardson DL, Harvey RD, Sharma MR, Hafez N, Hamilton E, Piha-Paul SA, Barve M, Wise-Draper T, Patel MR, Dowlati A, Pascuzzo J, Tang SC, Faltermeier C, Malinowska IA, Shtessel L, Striha A, Potocka E. A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors. Clin Ther. 2024 Mar;46(3):228-238. doi: 10.1016/j.clinthera.2024.01.004. Epub 2024 Feb 28.
Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Niraparib Tablet and Niraparib Capsule in people with Neoplasms, run by Tesaro, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase (time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03329001, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.