Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Bevacizumab

Niraparib

Endothelial Growth Factors

Mitogens

Adenosine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Participants will be administered bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute (min) intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib will be administered orally once a day continuously throughout each 21-day cycle (84-day cycle after amendment 2). On Day 1 of each cycle, niraparib will be administered upon completion of bevacizumab infusion. The starting dose of niraparib will be based on the participant's Baseline actual body weight or platelet count.

Niraparib will be administered orally once a day continuously throughout each 21 day cycle (84-day cycle after amendment 2). The starting dose of niraparib will be based on the participant's Baseline actual body weight or platelet count. Participants with a Baseline actual body weight of greater than equal to (\>=) 77 kg and Baseline platelet count of \>=150,000/ microliter (μL) will take 300 mg/day (3X100mg) at each dose administration. Participants with a Baseline actual body weight of less than (\<) 77 kg and/or Baseline platelet count of \<150,000/μL will take 200 mg (2X100 mg) at each dose administration.

Maintenance bevacizumab 15 mg/kg will be administered via a 30-minute IV infusion on Day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Bevacizumab will be administered for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of approximately 5 months of bevacizumab received with chemotherapy.

GSK Clinical Trials

Niraparib is an oral inhibitor of poly adenosine diphosphate-ribose polymerase (PARP)-1 and PARP-2. This study will evaluate safety and efficacy of niraparib combined with bevacizumab as maintenance treatment in participants with advanced (stage IIIB-IV) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer following front-line platinum-based chemotherapy with bevacizumab. Eligible participants who achieve complete response (CR), partial response (PR), or no evidence of disease (NED) following treatment with platinum-based chemotherapy in addition to bevacizumab will be enrolled in the study and will receive maintenance treatment with niraparib (for up to 3 years) combined with bevacizumab (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first. Participants who have not progressed after 3 years of niraparib maintenance treatment may continue with niraparib beyond 3 years if they are benefiting from treatment, upon consultation with Sponsor.

A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

A Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined With Bevacizumab as Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-line Platinum-based Chemotherapy With Bevacizumab

PFS rate at 18 months is defined as the percentage of participants who have not progressed or died within 18 months after niraparib combined with bevacizumab treatment initiation. Progression was assessed by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria per Investigator assessment and defined as a 20 percent (%) increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions. Survival rate is the percentage of participants without progression assessed by RECIST v1.1 or death by the landmark timepoint. Confidence intervals was constructed using exact method.

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

TEAE is defined as 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 non-serious TEAEs with 5% threshold are reported.

TEAE is defined as 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 Niraparib treatment discontinuation are reported.

TEAE is defined as 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 Niraparib dose reductions are reported.

Tesaro, Inc.

Safety Population comprised of participants who received any amount of study treatment (i.e., any amount of bevacizumab or niraparib during the study). The results presented are based on the primary analysis up to a maximum of 33.68 months. Data collection is still on-going and additional results will be provided after study completion.

Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.

Niraparib + Bevacizumab

Age, Continuous

Sex: Female, Male

White

Black or African American

Asian

American Indian or Alaska Native

Unknown

Race/Ethnicity, Customized

GSK Response Center

Intent-to-treat (ITT) Population comprised of all participants who received any amount of niraparib (at least 1 dose).

Progression Free Survival (PFS) Rate

Progression Free Survival by RECIST v 1.1

Overall Survival (OS)

RECIST or Cancer Antigen (CA)-125 Progression Free Survival

Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)

Time to First Subsequent Therapy (TFST)

Time to Second Subsequent Therapy (TSST)

Safety Population comprised of all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study).

Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs)

Number of Participants With TEAEs Leading to Niraparib Treatment Discontinuation

Number of Participants With TEAEs Leading to Niraparib Dose Reductions

Overall Study

Spots Global Cancer Trial Database for vascular endothelial growth factor (vegf) inhibitor