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

Sponsor:	Clovis Oncology, Inc.
Information provided by (Responsible Party):	Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:	NCT01009190

Purpose

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

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: PF-01367338 Drug: Carboplatin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin

U.S. FDA Resources

Further study details as provided by Clovis Oncology, Inc.:

Primary Outcome Measures:

Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Determination of F constant for bioavailability of oral PF-01367338 compared to intravenous PF-01367338 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Determination of food effect on oral PF-01367338 pharmacokinetics [ Time Frame: 18 month ] [ Designated as safety issue: No ]
Determination of effect of PF-013567338 administration on QTc prolongation test [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Characterization of PF-01367338 metabolite profile [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	February 2010
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ARM A Carboplatin plus PF-01367338	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 Drug: Carboplatin Standard doses of intravenous Carboplatin administered every 3 weeks
Experimental: ARM A EXPANSION Carboplatin plus PF-01367338	Drug: PF-01367338 RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle Drug: Carboplatin Standard doses of intravenous Carboplatin administered every 3 weeks

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009190

Contacts

Contact: Clovis Oncology Clinical Trial Information

Locations

France
Centre Rene Gauducheau	Withdrawn
Nantes, France, 44805
Institute Curie	Withdrawn
Paris, France, 75005
Institut Gustave Roussy	Withdrawn
Villejuif, France, 94805
Italy
Fondazione Centro San Raffaele del Monte Tabor	Withdrawn
Milano, Italy, 20132
United Kingdom
Churchill Hospital	Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Royal Marsden Hospital	Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
St. James's University Hospital	Withdrawn
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Belfast City Hospital	Recruiting
Belfast, United Kingdom, BT9 7AB
Beatson West of Scotland Cancer Centre	Recruiting
Glasgow, United Kingdom, G12 0YN
Kings College London	Recruiting
London, United Kingdom, SE1 9RT
Sir Bobby Robson Cancer Trials Research Centre	Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN

Sponsors and Collaborators

Clovis Oncology, Inc.

More Information

No publications provided

Responsible Party:	Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:	NCT01009190 History of Changes
Other Study ID Numbers:	CO-338-1014
Study First Received:	November 4, 2009
Last Updated:	October 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Clovis Oncology, Inc.:

Dose finding PARPi Chemotherapy

Additional relevant MeSH terms:

Antineoplastic Agents
Carboplatin
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012