Neoplasms

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All Conditions

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Gland and Hormone Related Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Esophageal Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Melanoma

Head and Neck Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Colonic Neoplasms

Endometrial Neoplasms

Urologic Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Esophageal Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplastic Processes

Breast Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Male Urogenital Diseases

Urologic Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Esophageal Cancer

Pancreatic Cancer

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Cola

Eligible participants will receive daily dosing of Niraparib.

Anjali Avadhani, MD

The purpose of this study is to further evaluate the efficacy and safety of niraparib in patients with locally advanced or metastatic solid tumors and a pathogenic or likely pathogenic tumor PALB2 (tPALB2) mutation.

Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients With PALB2 Mutations

To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1

To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1

To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

To evaluate ORR as assessed by Investigator using RECIST v1.1

To evaluate DOR as assessed by Investigator using RECIST v1.1

To evaluate PFS as assessed by Investigator using RECIST v1.1

To evaluate Clinical Benefit Rate (CBR) as assessed by ICR and Investigator

To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1

To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1

To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

GlaxoSmithKline

Tempus AI

Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase

Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase

Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase.

Single dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state.

Single dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal.

Niraparib Tablet

Niraparib Capsule

GSK Clinical Trials

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.

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

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

IPD for this study will be made available via the Clinical Study Data Request site.

Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.

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.

Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.

Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.

Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.

Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.

Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.

Blood samples were collected at indicated time points for pharmacokinetic assessment of tlag. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.

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.

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.

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.

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.

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.

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.

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. Data is not reported as participants response is still ongoing at the time of primary analysis.

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. Data is not reported as participants response is still ongoing at the time of primary analysis.

Tesaro, Inc.

Safety Population comprised of all participants who received any amount of niraparib during the PK Phase of the study. Results presented are based on primary analysis up to maximum 4.1 years. Results presented in this record correspond to the PK phase of the study. Analysis of end of study data is currently ongoing and will be provided in the study record after the analysis is completed.

Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.

Stage 1: Niraparib Tablet

Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.

Stage 1: Niraparib Capsule

Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.

Stage 2: Niraparib Tablet

Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.

Stage 2: Niraparib Capsule

Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.

Stage 3: Niraparib Tablet Fasted

Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.

Stage 3: Niraparib Tablet Fed

Participants received a single oral dose of 300 milligrams (mg) niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the extension phase were followed for up to 30 days (safety follow-up \[f/u\]) while participants eligible for extension phase proceeded for extension phase screening. Eligible participants then entered the extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.

Stage 1: Niraparib Tablet/Capsule

Participants received a single oral dose of 3x100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the extension phase were followed for up to 30 days (safety f/u) while participants eligible for extension phase proceeded for extension phase screening. Eligible participants then entered the extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.

Stage 1: Niraparib Capsule/Tablet

Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension phase were followed for up to 30 days (safety f/u) while participants eligible for Extension phase proceeded for Extension phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.

Stage 2: Niraparib Tablet/Capsule

Participants received a single oral dose of three 100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension phase were followed for up to 30 days (safety f/u) while participants eligible for Extension phase proceeded for Extension phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.

Stage 2: Niraparib Capsule/Tablet

Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension phase were followed for up to 30 days (safety f/u) while participants eligible for Extension phase proceeded for Extension phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.

Stage 3: Niraparib Tablet Fasted/Fed

Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension phase were followed for up to 30 days (safety f/u) while participants eligible for Extension phase proceeded for Extension phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.

Stage 3: Niraparib Tablet Fed/Fasted

Total

Age, Customized

Sex: Female, Male

Race/Ethnicity, Customized

Baseline characteristics were presented for Safety Population, all participants who received any amount of niraparib during the PK phase of study.

GSK Response Center

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.

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

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

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

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

Terminal Half-life (T1/2) for Niraparib-Stage 1 PK Phase

Apparent Total Body Clearance (CL/F) for Niraparib-Stage 1 PK Phase

Apparent Terminal Volume of Distribution (Vz/F) for Niraparib-Stage 1 PK Phase

Bioequivalence (BE) Evaluable Population included all participants who completed both the Study Drug and Washout/PK and had sufficient PK sample collection to accurately estimate PK parameters, without significant niraparib carryover and without events or protocol deviations deemed affect PK, in both Periods. Only those participants with estimable PK parameter data in both periods were analyzed.

AUC(0-t) for Niraparib-Stage 2 PK Phase

BE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.

AUC(0 to Inf) for Niraparib-Stage 2 PK Phase

Cmax for Niraparib-Stage 2 PK Phase

Tmax for Niraparib-Stage 2 PK Phase

T1/2 for Niraparib-Stage 2 PK Phase

CL/F for Niraparib-Stage 2 PK Phase

Vz/F for Niraparib-Stage 2 PK Phase

Food Effect (FE) Evaluable Population included all participants who completed both PK periods and had sufficient PK sample collection to accurately estimate PK parameters in both periods. Participants meeting non-evaluability criteria or having significant niraparib carryover (Baseline concentration \>5% of Cmax) were completely excluded from the FE Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.

AUC(0-t) for Niraparib-Stage 3 PK Phase

FE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.

AUC(0 to Inf) for Niraparib-Stage 3 PK Phase

Cmax for Niraparib-Stage 3 PK Phase

Tmax for Niraparib-Stage 3 PK Phase

T1/2 for Niraparib-Stage 3 PK Phase

CL/F for Niraparib-Stage 3 PK Phase

Vz/F for Niraparib-Stage 3 PK Phase

Time From Administration of the Dose to the First Quantifiable Concentration (Tlag) for Niraparib-Stage 3 PK Phase

TEAE

Serious TEAE

Safety Population comprised of all participants who received any amount of niraparib during the Stage 1 PK Phase of the study.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs-Stage 1 PK Phase (Periods 1 and 2 Only)

Number of Participants With TEAEs Leading to Discontinuation -Stage 1 PK Phase (Periods 1 and 2 Only)

Safety Population comprised of all participants who received any amount of niraparib during the Stage 2 PK Phase of the study.

Number of Participants With TEAEs and Serious TEAEs-Stage 2 PK Phase (Periods 1 and 2 Only)

Number of Participants With TEAEs-leading to Discontinuation Stage 2 PK Phase (Periods 1 and 2 Only)

Safety Population comprised of all participants who received any amount of niraparib during the Stage 3 PK Phase of the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors	NCT05169437	Solid Tumor Breast Tumor Colon Tumor, Ma... Lung Tumor Urologic Cancer Pancreatic Canc... Melanoma Metastatic Canc... Locally Advance... Esophageal Canc... Endometrial Can... Head and Neck C...	Niraparib	18 Years -	Tempus AI
Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule	NCT03329001	Neoplasms	Niraparib Table... Niraparib Capsu...	18 Years -	Tesaro, Inc.
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors	NCT05169437	Solid Tumor Breast Tumor Colon Tumor, Ma... Lung Tumor Urologic Cancer Pancreatic Canc... Melanoma Metastatic Canc... Locally Advance... Esophageal Canc... Endometrial Can... Head and Neck C...	Niraparib	18 Years -	Tempus AI

Spots Global Cancer Trial Database for zejula

Every month we try and update this database with for zejula cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for zejula

Every month we try and update this database with for zejula cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for zejula cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.