A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens
- Registration Number
- NCT01009190
- Lead Sponsor
- pharmaand GmbH
- Brief Summary
Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- Patients with histologically confirmed solid tumors, Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Patients with acceptable renal, hepatic, and bone marrow function
- Symptomatic and/or unstable brain metastases,
- Any cancer treatment within 4 weeks from study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARM A EXPANSION PF-01367338 Carboplatin plus PF-01367338 ARM A PF-01367338 Carboplatin plus PF-01367338 ARM A Carboplatin Carboplatin plus PF-01367338 ARM A EXPANSION Carboplatin Carboplatin plus PF-01367338
- Primary Outcome Measures
Name Time Method Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs) 18 months Dose-limiting toxicities and adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens 18 months rucaparib oral bioavailability
PARP activity and expression in peripheral blood lymphocytes (PBL) 18 months % PARP activity
Determination of food effect on oral PF-01367338 pharmacokinetics 18 month fasted and fed maximum plasma concentration (Cmax)
Determination of effect of PF-013567338 administration on QTc prolongation test 18 months electrocardiogram\[ecg\], QTcF, QTcB
Trial Locations
- Locations (6)
Churchill Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, Surrey, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Kings College London
🇬🇧London, United Kingdom
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Sir Bobby Robson Cancer Trials Research Centre
🇬🇧Newcastle Upon Tyne, United Kingdom