Clinical trial NCT01009190: A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens
Official title: A Parallel Arms Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Intravenous Poly (ADP-Ribose) Polymerase (PARP) Inhibitor PF-01367338 (AG-014699) In Combination With Several Chemotherapeutic Regimens In Adult Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Dose finding PARPi Chemotherapy
Lead sponsor: pharmaand GmbH
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors


Eligibility criteria: 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

Exclusion Criteria:

* Symptomatic and/or unstable brain metastases,
* Any cancer treatment within 4 weeks from study entry

Primary outcomes:
measure: Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)
timeFrame: 18 months
Secondary outcomes:
measure: Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
timeFrame: 18 months
measure: Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
timeFrame: 18 months
measure: Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
timeFrame: 18 months
measure: Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
timeFrame: 18 months
measure: Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
timeFrame: 18 months
measure: PARP activity and expression in peripheral blood lymphocytes (PBL)
timeFrame: 18 months
measure: Determination of food effect on oral PF-01367338 pharmacokinetics
timeFrame: 18 month
measure: Determination of food effect on oral PF-01367338 pharmacokinetics
timeFrame: 18 month
measure: Determination of effect of PF-013567338 administration on QTc prolongation test
timeFrame: 18 months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: Oxfordshire
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: Kings College London
city: Newcastle Upon Tyne
country: United Kingdom
facility: Sir Bobby Robson Cancer Trials Research Centre
Study officials:
References:
citation: 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.
citation: 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.