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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00654420 |
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 |
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Carcinoma, Non-Small-Cell Lung |
Drug: MK0646 Drug: Comparator: erlotinib |
Phase II |
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 |
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.
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 |
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 |
Study Director: | Medical Monitor | Merck |
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 |
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 |
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 |