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NCT01009190 Clinical Trial

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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01009190
Other study ID # CO-338-1014
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2010
Est. completion date April 2014

Study information
Verified date June 2023
Source zr Pharma & GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
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 Churchill Hospital Oxford Oxfordshire
United Kingdom Royal Marsden Hospital Sutton Surrey

Sponsors (1)
Lead Sponsor Collaborator
zr Pharma & GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 18 months
Secondary Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens Time to attain maximum plasma concentration [Tmax] 18 months
Secondary Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens maximum plasma concentration (CMax) 18 months
Secondary Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens area under plasma concentration curve (AUC) 18 months
Secondary Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens apparent terminal half-life (t1/2) 18 months
Secondary Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens rucaparib oral bioavailability 18 months
Secondary PARP activity and expression in peripheral blood lymphocytes (PBL) % PARP activity 18 months
Secondary 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] 18 month
Secondary Determination of food effect on oral PF-01367338 pharmacokinetics fasted and fed maximum plasma concentration (Cmax) 18 month
Secondary Determination of effect of PF-013567338 administration on QTc prolongation test electrocardiogram[ecg], QTcF, QTcB 18 months
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