Phase I Imaging Study Evaluating MK0646 in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer - Full Text View

Purpose

This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and MK0646 (Part II).

Condition	Intervention	Phase
Carcinoma, Non-Small Cell Lung	Drug: Comparator: MK0646 Drug: Comparator: erlotinib	Phase I

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer

Further study details as provided by Merck:

Primary Outcome Measures:

Validate imaging platform and molecular markers [ Time Frame: FDG response at Weeks 1 and 3 following chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival, overall survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	December 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental erlotinib	Drug: Comparator: MK0646 Part II: All patients will receive 1 week of erlotinib 150 mg tablets per day. Arm 1: Patients who experience a PET response will continue on erlotinib monotherapy until disease progression. Arm 2: Patients who fail to receive a PET response will continue to take erlotinib in combination with MK0646 10 mg/kg IV infusion once weekly. At the time of disease progression, patients on erlotinib monotherapy will be offered to crossover to MK0646 10 mg/kg IV infusion once weekly in combination with erlotinib. Drug: Comparator: erlotinib Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.
2: Experimental MK0646	Drug: Comparator: MK0646 Part II: All patients will receive 1 week of erlotinib 150 mg tablets per day. Arm 1: Patients who experience a PET response will continue on erlotinib monotherapy until disease progression. Arm 2: Patients who fail to receive a PET response will continue to take erlotinib in combination with MK0646 10 mg/kg IV infusion once weekly. At the time of disease progression, patients on erlotinib monotherapy will be offered to crossover to MK0646 10 mg/kg IV infusion once weekly in combination with erlotinib.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
Patient has measurable disease
Patient has had one or two chemotherapy regimens for recurrent or metastatic disease
Patient has archival tumor tissue available
Patient has accessible tumor and consents to undergo a tumor biopsy [Part II only]
Patient is 18 years of age or older
Patient has a performance status of 0-2 on ECOG scale
Women of childbearing potential have a negative pregnancy test
Patients in Part I must be Asian female non-smoker with non-squamous histology or have documented EGFR mutation or EGFR gene amplification

Exclusion Criteria:

Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
Patient has not recovered from adverse events from previous therapy within 4 weeks
Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
Patient has untreated brain metastases
Patient has had radiotherapy or thoracic surgery within 3 months prior to entering the study
Patient is taking part in another clinical study
Patient abuses drugs or alcohol
Patient is pregnant or breastfeeding
Subject is HIV positive
Patient has active hepatitis
Patient is using growth hormone or growth hormone inhibitors
Patient has poorly controlled diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729742

Contacts


Contact: Toll Free Number	1-888-577-8839

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_518, MK0646-008
First Received:	August 4, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00729742
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Erlotinib

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00729742