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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00848718 |
The purpose of this study is to compare the safety and tolerability of two different dose levels of MK2206 in combination with chemotherapy and targeted therapy agents in patients with locally advanced or metastatic solid tumors.
Condition | Intervention | Phase |
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Locally Advanced, Metastatic Solid Tumors |
Drug: MK2206 combined with carboplatin + paclitaxel Drug: MK2206 combined with docetaxel. Drug: MK2206 combined with Erlotinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Phase I Dose Escalation Study of MK2206 in Combination With Standard Doses of Selected Chemotherapeutic or Targeted Agents in Patients With Locally Advanced or Metastatic Solid Tumors. |
Estimated Enrollment: | 130 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MK2206 combined with Carboplatin + Paclitaxel.
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Drug: MK2206 combined with carboplatin + paclitaxel
MK2206 given on days 1, 3, 5, and 7 of the 21 day cycle(either 45 mg or 60 mg). On day 1 of each 21 day cycle, Carboplatin + paclitaxel is given by vein.
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2: Experimental
MK2206 combined with Docetaxel.
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Drug: MK2206 combined with docetaxel.
MK2206 given on days 1, 3, 5, and 7 of the 21 day cycle (either 45 mg or 60 mg). On day 1 of each 21 day cycle, docetaxel is given by vein. In this treatment arm, an oral corticosteroid is to be taken by mouth every day.
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3: Experimental
MK2206 combined with Erlotinib
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Drug: MK2206 combined with Erlotinib
MK2206 given by mouth every other day (either 45 mg or 60 mg). In addition, Erlotinib is given daily by mouth in a continuous 21 day cycle for the duration of the study.
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Ages Eligible for Study: | 18 Years to 91 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 |
United States, Florida | |
Call for Information | Recruiting |
Tampa, Florida, United States, 33612 | |
United States, Texas | |
Call for Information | Recruiting |
San Antonio, Texas, United States, 78229 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2009_547, MK2206-003 |
Study First Received: | February 19, 2009 |
Last Updated: | August 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00848718 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Erlotinib Docetaxel Paclitaxel Tubulin Modulators |
Antimitotic Agents Carboplatin Protein Kinase Inhibitors Antineoplastic Agents, Phytogenic |
Erlotinib Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Carboplatin Antimitotic Agents |
Protein Kinase Inhibitors Pharmacologic Actions Docetaxel Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |