Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: CP-751,871; Drug: carboplatin; Drug: erlotinib; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00147537

A4021002

Details and patient eligibility

About

Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.

Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer

Enrollment: 282 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of advanced/metastatic lung cancer

Exclusion criteria

• Previous treatment with chemotherapy
• Uncontrolled diabetes
• History/active cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

Phase 2 (Arms A & B)

Experimental group

Description:

CP-751,871 + paclitaxel + carboplatin

Treatment:

Drug: CP-751,871

Drug: carboplatin

Drug: paclitaxel

Drug: carboplatin

Drug: paclitaxel

Drug: CP-751,871

Phase 1b

Experimental group

Description:

1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin 2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib

Treatment:

Drug: CP-751,871

Drug: carboplatin

Drug: paclitaxel

Drug: erlotinib

Drug: carboplatin

Drug: paclitaxel

Drug: CP-751,871