MDV3800-13, Open Label, Extended Treatment with Talazoparib
Research type
Research Study
Full title
A Single Arm, Open Label, Multicenter, Extended Treatment, Safety Study in Patients Treated With Talazoparib
IRAS ID
211856
Contact name
Johann de Bono
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2016-001972-31
Clinicaltrials.gov Identifier
108,708, IND
Duration of Study in the UK
4 years, 2 months, 2 days
Research summary
This is a single-arm, open-label (the dose given is known by the investigator and the patient), extended treatment, safety study in patients treated with talazoparib (also known as MDV3800, BMN 673) as a single agent or in combination with another agent in qualifying originating clinical studies sponsored by Medivation. The safety and tolerability of long-term talazoparib use will be evaluated, and the data collected will be limited to safety assessments. The study provides access to single-agent talazoparib for qualifying patients who may benefit from continuing treatment with talazoparib.
This multi-centre study will take place at about 50 research centres around the world, approximately 150 participants will take part following completion of their originating study.
The study consists of Screening, Treatment and Post-Treatment Safety Follow-Up. Following completion of the Screening period, to confirm the participant’s suitability for the study, they will move into the Treatment period. This will consist of clinic visits approximately every 4 weeks for the first 24 weeks and then approximately every 8 weeks thereafter or as clinically indicated until the investigator considers treatment to no longer be beneficial or any other study discontinuation criteria are met. The Post-Treatment Safety Follow-Up visit will occur 30 days after the last dose of talazoparib.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/1777
Date of REC Opinion
29 Nov 2016
REC opinion
Further Information Favourable Opinion