MedTrace Logo

Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer

NCT02354131 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-08-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Niraparib

Niraparib versus Bevacizumab-Niraparib combo

DRUG

Bevacizumab

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Gynecologic Cancer Intergroup (GCIG)

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Myriad Genetics, Inc.

    collaborator INDUSTRY

  • Nordic Society of Gynaecological Oncology - Clinical Trials Unit

    lead OTHER

Principal Investigators

  • Mansoor R Mirza, MD · Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-15
Primary Completion
2018-11-15
Completion
2021-12-15

Countries

  • United States
  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02354131 on ClinicalTrials.gov