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

pharmaand

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: PF-01367338; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01009190

CO-338-1014

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

ARM A

Experimental group

Description:

Carboplatin plus PF-01367338

Treatment:

Drug: Carboplatin

Drug: Carboplatin

Drug: PF-01367338

Drug: PF-01367338

ARM A EXPANSION

Experimental group

Description:

Carboplatin plus PF-01367338

Treatment:

Drug: Carboplatin

Drug: Carboplatin

Drug: PF-01367338

Drug: PF-01367338