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Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer — AVANIRA3  

Neoplasms Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Adnexal Diseases
  • Angiogenesis
  • Antineoplastic Agents
  • Bevacizumab
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Endocrine Gland Neoplasms
  • Endocrine System Diseases
  • Enzyme Inhibitors
  • Fallopian Tube Neoplasms
  • Genital Diseases, Female
  • Genital Neoplasms, Female
  • Gonadal Disorders
  • Homologous Recombination Deficiency
  • Molecular Mechanisms of Pharmacological Action
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neoplasms, Glandular and Epithelial
  • Ovarian Diseases
  • Ovarian Neoplasms
  • Urogenital Neoplasms
Clinical Trial Details
NCT number NCT04556071
Study type Interventional
Source Jiangsu Cancer Hospital (Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital)
Contact Xiaoxiang Chen, MD,PhD
Phone +86 13851647229
Email cxxxxcyd@gmail.com
Status Recruiting
Phase Phase 2
Start date November 6, 2020
Completion date October 1, 2022
View Details
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