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A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens

Phase 1
Completed
Conditions
Advanced Solid Tumors
Interventions
Drug: PF-01367338
Drug: Carboplatin
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
Inclusion Criteria
  • Patients with histologically confirmed solid tumors, Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Patients with acceptable renal, hepatic, and bone marrow function
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Exclusion Criteria
  • Symptomatic and/or unstable brain metastases,
  • Any cancer treatment within 4 weeks from study entry
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ARM A EXPANSIONPF-01367338Carboplatin plus PF-01367338
ARM APF-01367338Carboplatin plus PF-01367338
ARM ACarboplatinCarboplatin plus PF-01367338
ARM A EXPANSIONCarboplatinCarboplatin plus PF-01367338
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens18 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 pharmacokinetics18 month

fasted and fed maximum plasma concentration (Cmax)

Determination of effect of PF-013567338 administration on QTc prolongation test18 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

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