Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer (AVANOVA)
|ClinicalTrials.gov Identifier: NCT02354131|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2015
Last Update Posted : February 2, 2018
Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS)
PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer; the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as in gBRCAwt, HRD population but also in HRD negative disease.
In the same population there is level one evidence that bevacizumab is beneficial. And a phase two randomized study has indicated that combination of a PARP inhibitor with anti-angiogenic drug is superior to PARP inhibitor alone.
The question is:
Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability and efficacy of niraparib-bevacizumab combination against niraparib.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Niraparib Drug: Bevacizumab||Phase 1 Phase 2|
Part 1: This is a single-centre, phase 1a, open-label, dose-escalation study to evaluate the safety and tolerability of bevacizumab-niraparib combination and determine the RP2D in patients with platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The standard 3+3 design will be used. Part 2: (n=94) This multicenter, prospective, open-label, randomized phase 2 study is evaluating the efficacy of niraparib against niraparib-bevacizumab combination in Women with platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Stratification: Patients are stratified according to:
- HRD status (positive/negative)
- Treatment-Free interval to prior therapy (6-12 months > 12 months) Randomization: 1:1 randomization
Study arms: Patients are randomized to one of the two treatment arms:
Arm 1: Niraparib monotherapy until progression. Arm 2: Niraparib-bevacizumab combination therapy until progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Part 1: AVANOVA1 - A Phase I Study to Evaluate the Safety and Tolerability of Bevacizumab-niraparib Combination Therapy and Determine the Recommended Phase 2 Dose (RP2D) in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Part 2: AVANOVA2 - A Two-arm, Open-label, Phase II Randomized Study to Evaluate the Efficacy of Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer.|
|Actual Study Start Date :||February 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2020|
U.S. FDA Resources
Experimental: Niraparib monotherapy
Niraparib mono therapy until progression
Niraparib versus Bevacizumab-Niraparib combo
Experimental: Niraparib-bevacizumab combination
Niraparib-bevacizumab combination therapy until progression
Niraparib versus Bevacizumab-Niraparib comboDrug: Bevacizumab
- Progression free survival [ Time Frame: 30 months ]This is pick the winer trial. The best arm will be used for phase 3 trial against standard of care.
- Disease Control Rate [ Time Frame: 30 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354131
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States|
|Copenhagen, Sjaelland, Denmark, 2100|
|Study Chair:||Mansoor R Mirza, MD||Nordic Society for Gynaecologic Oncology|