Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Increasing doses of single lead-in (Day -10) intravenous and daily oral PF-01367338 administered from Day 1 to Day 14 every 3-week cycle
Standard doses of intravenous Carboplatin administered every 3 weeks
RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)
Dose-limiting toxicities and adverse events
Time frame: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
Time to attain maximum plasma concentration \[Tmax\]
Time frame: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
maximum plasma concentration (CMax)
Time frame: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
area under plasma concentration curve (AUC)
Time frame: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
apparent terminal half-life (t1/2)
Time frame: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
rucaparib oral bioavailability
Time frame: 18 months
PARP activity and expression in peripheral blood lymphocytes (PBL)
% PARP activity
Time frame: 18 months
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Standard doses of intravenous Carboplatin administered every 3 weeks
Kings College London
London, United Kingdom
Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, United Kingdom
Determination of food effect on oral PF-01367338 pharmacokinetics
fasted and fed parameters area under the plasma concentration-time curve from time 0 to the last recorded observation \[AUClast\]
Time frame: 18 month
Determination of food effect on oral PF-01367338 pharmacokinetics
fasted and fed maximum plasma concentration (Cmax)
Time frame: 18 month
Determination of effect of PF-013567338 administration on QTc prolongation test
electrocardiogram\[ecg\], QTcF, QTcB
Time frame: 18 months