Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer (AVANIRA3)
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|ClinicalTrials.gov Identifier: NCT04556071|
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : September 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Niraparib Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||October 1, 2022|
Experimental: Niraparib-bevacizumab combination
Niraparib-bevacizumab combination therapy until disease progression
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.
Other Name: Zejula
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.
Other Name: Avastin
- Overall Response Rate (ORR) [ Time Frame: at 6 months ]ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.
- Progression Free Survival (PFS) [ Time Frame: Through study completion, an average of 1 year ]PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.
- Disease Control Rate (DCR) [ Time Frame: at 6 months ]Disease control rate is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.
- Duration of Response (DOR) [ Time Frame: Through study completion, an average of 1 year ]DOR is defined as the time from the first date of response until the date of first documented progression.
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Through study completion, an average of 1 year ]To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556071
|Contact: Xiaoxiang Chen, MD,PhD||+86 email@example.com|
|Contact: Jing Ni, MD||+86 firstname.lastname@example.org|
|Study Chair:||Xiaoxiang Chen, MD,PhD||Jiangsu Cancer Institute & Hospital|