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

Sponsor
Xiaoxiang Chen
Study ID
NCT04556071
Phase
PHASE2
Status
Unknown

Conditions

  • Adnexal Diseases
  • Angiogenesis
  • Antineoplastic Agents
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Bevacizumab
  • 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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    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.
  • Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 6, 2020
Status verified
Nov 2020
Primary completion
Mar 1, 2022
Completion
Oct 1, 2022

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib-bevacizumab combination
    Niraparib-bevacizumab combination therapy until disease progression

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: at 6 months ]

Central Contacts

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