A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens
NCT ID: NCT01009190
Last Updated: 2023-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
85 participants
INTERVENTIONAL
2010-02-28
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM A
Carboplatin plus PF-01367338
PF-01367338
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
Carboplatin
Standard doses of intravenous Carboplatin administered every 3 weeks
ARM A EXPANSION
Carboplatin plus PF-01367338
PF-01367338
RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle
Carboplatin
Standard doses of intravenous Carboplatin administered every 3 weeks
Interventions
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PF-01367338
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
Carboplatin
Standard doses of intravenous Carboplatin administered every 3 weeks
PF-01367338
RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle
Carboplatin
Standard doses of intravenous Carboplatin administered every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients with acceptable renal, hepatic, and bone marrow function
Exclusion Criteria
* Any cancer treatment within 4 weeks from study entry
18 Years
ALL
No
Sponsors
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pharmaand GmbH
INDUSTRY
Responsible Party
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Locations
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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
Kings College London
London, , United Kingdom
Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.
Wilson RH, Evans TJ, Middleton MR, Molife LR, Spicer J, Dieras V, Roxburgh P, Giordano H, Jaw-Tsai S, Goble S, Plummer R. A phase I study of intravenous and oral rucaparib in combination with chemotherapy in patients with advanced solid tumours. Br J Cancer. 2017 Mar 28;116(7):884-892. doi: 10.1038/bjc.2017.36. Epub 2017 Feb 21.
Other Identifiers
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CO-338-1014
Identifier Type: -
Identifier Source: org_study_id
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