NCT04556071

Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer

A Single-arm, Prospective, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Xiaoxiang Chen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Niraparib is an oral, potent and highly selective PARP1/2 inhibitor. It can be used as a single drug in HRD positive ovarian cancer patients for multi-line therapy. Bevacizumab is a recombinant humanized monoclonal antibody that inhibits tumor angiogenesis and is also recommended for the treatment of recurrent ovarian cancer. Clinical studies showed that niraparib combined with bevacizumab could significantly prolong progression free survival of platinum sensitive recurrent ovarian cancer. We intend to conduct a single-arm, prospective, open-label, phase II study to observe the efficacy and safety of niraparib combined with bevacizumab in the treatment of FIGO III/IV platinum refractory/resistant ovarian cancer, fallopian tube cancer and primary peritoneal cancer. The results are expected to provide more effective and precise treatment for platinum resistant recurrent/refractory ovarian cancer patients.

Detailed description

The study is a single-arm, prospective, open-label, phase II study to observe the efficacy and safety of niraparib combined with bevacizumab in the treatment of FIGO III/IV platinum refractory/resistant ovarian cancer, fallopian tube cancer and primary peritoneal cancer.The primary end point is the objective response rate, and the secondary end points are progression free survival, duration of remission, disease control rate and safety. We also stratified analysis the level of tumor load, the status of BRCA and HRD on the efficacy and safety.

Conditions

• Ovarian Neoplasms
• Fallopian Tube Neoplasms
• Endocrine Gland Neoplasms
• Neoplasms by Site
• Neoplasms
• Genital Neoplasms, Female
• Urogenital Neoplasms
• Neoplasms, Glandular and Epithelial
• Neoplasms by Histologic Type
• Carcinoma, Ovarian Epithelial
• Ovarian Diseases
• Adnexal Diseases
• Genital Diseases, Female
• Endocrine System Diseases
• Gonadal Disorders
• Carcinoma
• Bevacizumab
• Enzyme Inhibitors
• Antineoplastic Agents
• Molecular Mechanisms of Pharmacological Action
• Angiogenesis
• BRCA1 Mutation
• BRCA2 Mutation
• Homologous Recombination Deficiency

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib will be administered orally once a day continuously throughout each 21-days cycle. The initial dose will be based on the participant's basal body weight or platelet count. Participants with basal body weight≥77 kg and basal platelet count of≥150,000/microliter (μL) will take 300 mg daily. While participants with basal body weight\<77 kg and/or basal platelet count \<150,000/μL will take 200 mg daily.
DRUG	Bevacizumab	The dose of Bevacizumab will be 15 mg/kg that administered via a 30-minute intravenous 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.

Timeline

• Start date: 2020-11-06
• Primary completion: 2022-03-01
• Completion: 2022-10-01
• First posted: 2020-09-21
• Last updated: 2020-11-10

Locations

1 site across 1 country: China