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

NCT ID: NCT01121575

Last Updated: 2015-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-02-28

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

PF-02341066

Intervention Type: DRUG

Arm 1: The starting dose will be 200 mg by mouth, twice a day of PF 02341066 in tablet form The dose of each drug in the combination \[PF-02341066 and PF-00299804\] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.

PF-00299804

Intervention Type: DRUG

Arm 1: The starting dose will be 30 mg by mouth once a day of PF-0029804 in tablet form. The dose of each drug in the combination \[PF-02341066 and PF-00299804\] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.

Arm 2

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).

Group Type: EXPERIMENTAL

PF-02341066

Intervention Type: DRUG

Arm 2: With progressive disease the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).

PF-00299804

Intervention Type: DRUG

Arm 2: The dose of 45 mg by mouth once a day of PF-00299804 in tablet form until progressive disease and then the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).

Interventions

PF-02341066

Arm 1: The starting dose will be 200 mg by mouth, twice a day of PF 02341066 in tablet form The dose of each drug in the combination \[PF-02341066 and PF-00299804\] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.

Intervention Type: DRUG

PF-00299804

Arm 1: The starting dose will be 30 mg by mouth once a day of PF-0029804 in tablet form. The dose of each drug in the combination \[PF-02341066 and PF-00299804\] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.

Intervention Type: DRUG

PF-02341066

Arm 2: With progressive disease the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).

Intervention Type: DRUG

PF-00299804

Arm 2: The dose of 45 mg by mouth once a day of PF-00299804 in tablet form until progressive disease and then the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).

Intervention Type: DRUG

Other Intervention Names

cMET inhibitor; panHER inhibitor; cMET inhibitor; panHER inhibitor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Clinical Trials Office University of Colorado Hospital (CTO)

Aurora, Colorado, United States

DRUG SHIPMENT: University of Colorado Cancer Center

Aurora, Colorado, United States

Rocky Mountain Lions Eye Institute

Aurora, Colorado, United States

University of Colorado Hospital

Aurora, Colorado, United States

CCR, National Cancer Institute

Bethesda, Maryland, United States

Drug Shipment Only

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Drug Shipment Only

Boston, Massachusetts, United States

Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology

East Melbourne, Victoria, Australia

Countries

United States; Australia

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081006&StudyName=A%20Study%20Of%20Combined%20C-%20MET%20Inhibitor%20And%20PAN-HER%20Inhibitor%20%28PF-02341066%20And%20PF-00299804%29%20In%20Patients%20With%20Non-%20Small%20Cell%20Lung%20Can

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Other Identifiers

A8081006

Identifier Type: -

Identifier Source: org_study_id