NCT01009190

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: pharmaand GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2009-11-06
• Last updated: 2023-06-08

Locations

6 sites across 1 country: United Kingdom