A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer

Pfizer

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: PF-00299804; Drug: PF-02341066

Study type: Interventional

Funder types: Industry

Identifiers

NCT01121575

A8081006

Details and patient eligibility

About

Lung cancer tumors become resistant to the first generation epidermal growth factor receptor (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell signaling pathways: the cMET pathway and the EGFR pathway. Both resistance mechanisms can occur at the same time, in the same patient and even in the same tumor. This study combines a second generation EGFR inhibitor and a cMET inhibitor to block both these pathways in order to overcome resistance and treat this disease.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• advanced non small cell lung cancer (dose escalation phase)
• acquired resistance to erlotinib or gefitinib (expansion phase)
• mandatory entrance biopsy (expansion phase)

Exclusion criteria

• interstitial lung disease
• unstable brain metastases
• leptomeningeal disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Arm 1

Experimental group

Description:

PF-02341066 AND PF-00299804: Patients will be treated with combined cMET inhibitor (PF-02341066) and panHER inhibitor (PF-00299804).

Treatment:

Drug: PF-00299804

Drug: PF-00299804

Drug: PF-02341066

Drug: PF-02341066

Arm 2

Experimental group

Description:

PF-00299804 FOLLOWED BY COMBINED PF-02341066 AND PF-00299804: Patients will be treated with single agent panHER inhibitor (PF-00299804) until disease progression and then with the maximum tolerated combined dose of cMET inhibitor (PF-02341066) and panHER inhibitor (PF-00299804).

Treatment:

Drug: PF-00299804

Drug: PF-00299804

Drug: PF-02341066

Drug: PF-02341066