Trial | NCT01009190  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    85
Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors
Study Started
Feb 28
2010
Primary Completion
Apr 30
2014
Study Completion
Apr 30
2014
Last Update
Jun 08
2023

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

ARM A Experimental

Carboplatin plus PF-01367338

ARM A EXPANSION Experimental

Carboplatin plus PF-01367338

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
No Results Posted