A Phase 3 Veliparib plus Chemotherapy study in Ovarian Cancer
Research type
Research Study
Full title
A Phase 3 Placebo-Controlled Study of Carboplatin/Placlitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
IRAS ID
173940
Contact name
Shibani Nicum
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co.KG
Eudract number
2014-005070-11
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Currently, the standard of care for the primary treatment of ovarian, fallopian tube, or primary peritoneal cancer is a combination of carboplatin and paclitaxel approved chemotherapy drugs. Veliparib is a 'PARP inhibitor' which is a substance that may stop cancer cells from repairing DNA, and therefore may make chemotherapy better at killing cells.
The study will consist of four phases: Pre-Therapy, Combination Therapy, Maintenance Therapy and a Long Term Follow Up. All patients will be randomised to one of three arms where they will receive carboplatin and paclitaxel plus placebo or veliparib followed by either a placebo or veliparib maintenance therapy.
The trial will see which treatment is better at controlling the cancer by measuring how long patients can go before their disease progresses. This is known as progression-free Survival. This study will be conducted only in female patients with previously untreated Stage III or IV high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. It is the hope that patients could benefit if tumour growth is inhibited, therefore improving their condition and survival time. Information gathered may help improve future treatment of the disease.
Patients will attend regular study visits at either a hospital or clinic and have up to 36 cycles of treatment. The effect of the treatments on the cancer will be checked at each study visit by having scans, blood tests, checking for side effects and completing questionnaires.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0359
Date of REC Opinion
22 Jun 2015
REC opinion
Favourable Opinion