BMN 673 in Patients with Advanced or Recurrent Solid Tumours A1 9DEC10
Research type
Research Study
Full title
A Phase 1/2, First in Human, Single-arm, Open-label Study of Once a Day, Orally Administered BMN 673 in Patients with Advanced or Recurrent Solid Tumors
IRAS ID
68163
Contact name
Johann S De Bono
Sponsor organisation
Medivation, Inc.
Eudract number
2010-023062-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of talazoparib (BMN 673) in patients with advanced tumours, starting with;
Escalation phase (part 1) - 3 patients will be enrolled to take increasing doses of BMN 673 until a patient experiences a DLT Dose limiting toxicity), then the number of pts increase to 6. This is based on the 3+3 design. If ≥2 patients (of 3 or 6) experiences a DLT at a given dose level, then that dose level will be considered to have exceeded the MTD (Maximum Tolerated Dose). The MTD will be defined as the highest dose level at which ≤1 patient experience DLTs. Once the maximum tolerated dose has been defined then the Expansion Phase (Part) 2 will start.
Part 1 - A single dose of BMN 673 will be given to 3 patients on Cycle 1 Day 1 followed by 6 days off treatment for pharmacokinetics and observation. Daily treatment will start on Cycle 1 Day 8 taking BMN 673 for 28 consecutive days, followed by 7 days off treatment. Thereafter they will begin daily dosing of BMN 673 in repeated 28 day cycles.
Part 2 - will only continue after the Maximum Tolerated Dose (MTD) has been determined. 20 patients will be enrolled to start taking Cycle 1 Day 1 daily dosing in repeated 28 day cycles.REC name
London - Chelsea Research Ethics Committee
REC reference
11/LO/0153
Date of REC Opinion
19 Apr 2011
REC opinion
Further Information Favourable Opinion