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 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors
Both
Advanced Solid Tumors
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)
Outcome Time Frame:
18 months
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
CO-338-1014
NCT ID:
NCT01009190
Start Date:
February 2010
Completion Date:
December 2013
Related Keywords:
- Advanced Solid Tumors
- Dose finding PARPi Chemotherapy
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