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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00654420

Purpose

This study will look for the highest tolerated dose of MK0646 given in combination with erlotinib. The study will also investigate how well MK0646 works in conjunction with erlotinib at treating recurrent non-small cell lung cancer.

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

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study
Official Title:	An Open Label, Randomized Phase I/IIa Trial Evaluating MK0646 in Combination With Erlotinib for Patients With Recurrent Non-Small Cell Lung Cancer

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability of the combination treatment; progression-free survival will be assessed using physical examinations, vital signs, ECOG performance status, complete blood count with differential and platelets, serum chemistry, adverse experience [ Time Frame: After each dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

response rate and overall survival [ Time Frame: After each dose of study drug ] [ Designated as safety issue: No ]

Estimated Enrollment:	68
Study Start Date:	March 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase 1 & 2: Experimental The Phase I part of the study will be a safety assessment of erlotinib in combination with MK0646. Erlotinib will be administrated orally by mouth (PO) at 150 mg daily, and MK0646 IV at 5 mg/kg weekly and then dose escalate to 10 mg/kg weekly following the a dose limiting toxicity (DLT) then the dose will be considered. Phase II will be IV at 5 mg/kg weekly. The minimum Phase II dose of MK0646 will be 5 mg/kg weekly. If the 5 mg/kg dose is not tolerated, then Phase I will be terminated and Phase II will not be conducted.	Drug: MK0646 MK0646 IV infusion over 60 minutes at 5 mg/kg weekly and then dose escalate to 10 mg/kg weekly following the dose limiting toxicity (DLT) then the dose will be considered. Phase II will be IV infusion over 60 minutes at 5 mg/kg weekly. Drug: Comparator: erlotinib Erlotinib will be administrated orally by mouth (PO) at 150 mg daily.

Arms

Assigned Interventions

Phase 1 & 2: Experimental

The Phase I part of the study will be a safety assessment of erlotinib in combination with MK0646. Erlotinib will be administrated orally by mouth (PO) at 150 mg daily, and MK0646 IV at 5 mg/kg weekly and then dose escalate to 10 mg/kg weekly following the a dose limiting toxicity (DLT) then the dose will be considered. Phase II will be IV at 5 mg/kg weekly. The minimum Phase II dose of MK0646 will be 5 mg/kg weekly. If the 5 mg/kg dose is not tolerated, then Phase I will be terminated and Phase II will not be conducted.

Drug: MK0646

MK0646 IV infusion over 60 minutes at 5 mg/kg weekly and then dose escalate to 10 mg/kg weekly following the dose limiting toxicity (DLT) then the dose will be considered. Phase II will be IV infusion over 60 minutes at 5 mg/kg weekly.

Drug: Comparator: erlotinib

Erlotinib will be administrated orally by mouth (PO) at 150 mg daily.

Detailed Description:

MK0646 is a humanized monoclonal antibody (mAb) that targets the IGF-1R
MK0646 may act through
Inhibition of IGF-1-mediated cell signaling to cause reductions in tumor growth and spread
Antibody dependent cell-mediated cytotoxicity
In preclinical studies, MK0646 improved the activity of an anti-EGFR mAb and the activity of Erlotinib, a small molecule inhibitor of EGFR Trial Duration of Treatment: Subjects will continue on the study for as long as their disease is not progressing and they do not have unmanageable side effects from the treatment.

Eligibility

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

Criteria

Inclusion Criteria:

Subject has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer that has relapsed after chemotherapy/chemoradiotherapy
Subject has had at least one chemotherapy regimen for recurrent or metastatic disease
Subject is 18 years of age or older
Subject has a performance status of 0-2 on ECOG scale
Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

Subject has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
Subject has not recovered from adverse events from previous therapy within 4 weeks
Subject has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
Subject has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
Subject has had more than 2 systemic chemotherapies for metastatic disease
Subject has not completed radiotherapy with complete resolution of toxicities at least 2 weeks before starting in the study
Subject is taking part in another clinical study
Subject has a primary central nervous system tumor
Subject abuses drugs or alcohol
Subject is pregnant or breastfeeding
Subject is HIV positive
Subject has a history of hepatitis B or C
Subject is using growth hormone or growth hormone inhibitors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654420

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Missouri
Call for Information	Recruiting
Saint Louis, Missouri, United States, 63110-1093
United States, Montana
Call for Information	Recruiting
Billings, Montana, United States, 59101-0998
United States, Pennsylvania
Call for Information	Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Call for Information	Recruiting
Nashville, Tennessee, United States, 37232-6307
Austria
Merck Sharp & Dohme Gmbh	Recruiting
Vienna, Austria, 1220
Contact: Andras Festa 43-1-26044-130
Canada, Quebec
Merck Frosst Canada Ltd.	Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Michel Cimon 514-428-2605
Denmark
Merck Sharp & Dohme	Recruiting
Glostrup, Denmark, 2600
Contact: Christina Wengel 45-43-28-77-90
France
Laboratoires Merck Sharp & Dohme - Chibret	Recruiting
Paris Cedex 8, France, 75114
Contact: Jean-Marie Goehrs 33-1-4754-89-90
Germany
Msd Sharp & Dohme Gmbh	Recruiting
Haar, Germany, 85540
Contact: Thomas Lang 49-89-4561-1536
Italy
Merck Sharp & Dohme (Italia) S.P.A.	Recruiting
Roma, Italy, 191
Contact: Gianfranco Botta 39 06 36 191187
Russian Federation
Merck Sharp & Dohme IDEA, Inc.	Recruiting
Moscow, Russian Federation, 121059
Contact: Tatiana Serebriakova 7-495-941-8264
Spain
Merck Sharp & Dohme De Espana, S.A.E.	Recruiting
Madrid, Spain, 28027
Contact: Jorge Gonzalez-Esteban 34-91-3210-728
Sweden
Merck Sharp & Dohme (Sweden) AB	Recruiting
Sollentuna, Sweden, 192 07
Contact: Roger Juhlin 46-8-626-1 458

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_605, MK0646-007
Study First Received:	March 26, 2008
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00654420 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer

Protein Kinase Inhibitors
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009