A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003)
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ClinicalTrials.gov Identifier: NCT00848718 |
Recruitment Status :
Completed
First Posted : February 20, 2009
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
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Tracking Information | |||||||
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First Submitted Date ICMJE | February 19, 2009 | ||||||
First Posted Date ICMJE | February 20, 2009 | ||||||
Results First Submitted Date ICMJE | October 14, 2019 | ||||||
Results First Posted Date ICMJE | November 12, 2019 | ||||||
Last Update Posted Date | November 12, 2019 | ||||||
Actual Study Start Date ICMJE | March 17, 2009 | ||||||
Actual Primary Completion Date | May 19, 2011 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
To assess the safety, tolerability and side effects of MK2206 when given in combination with selected chemo and targeted agents in patients with locally advanced or metastatic solid tumors by monitoring of adverse events and clinical/lab measurements. [ Time Frame: 4 weeks ] | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Number of Participants Who Had a Tumor Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Up to approximately 4 months (6 cycles) ] Tumor response was assessed using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and was recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): disappearance of all target lesions and Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions. The number of participants who had a tumor response of either CR or PR is presented.
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Original Secondary Outcome Measures ICMJE |
To explore the anti-tumor activity of MK2206 in combination with either carboplatin + paclitaxel, docetaxel or erlotinib in patients with advanced solid tumors as assessed by imaging and clinical and laboratory evaluations. [ Time Frame: 4 weeks ] | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003) | ||||||
Official Title ICMJE | A Phase I Dose Escalation Study of MK-2206 in Combination With Standard Doses of Selected Chemotherapies or Targeted Agents in Patients With Locally Advanced or Metastatic Solid Tumors | ||||||
Brief Summary | The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors. The primary hypotheses are that administration of MK-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (DLT) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (MTD) in each of the 3 combinations. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Locally Advanced, Metastatic Solid Tumors | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Molife LR, Yan L, Vitfell-Rasmussen J, Zernhelt AM, Sullivan DM, Cassier PA, Chen E, Biondo A, Tetteh E, Siu LL, Patnaik A, Papadopoulos KP, de Bono JS, Tolcher AW, Minton S. Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors. J Hematol Oncol. 2014 Jan 3;7:1. doi: 10.1186/1756-8722-7-1. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
77 | ||||||
Original Estimated Enrollment ICMJE |
130 | ||||||
Actual Study Completion Date ICMJE | May 17, 2012 | ||||||
Actual Primary Completion Date | May 19, 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria :
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | United Kingdom, United States | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00848718 | ||||||
Other Study ID Numbers ICMJE | 2206-003 2009_547 MK-2206-003 ( Other Identifier: Merck ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Merck Sharp & Dohme LLC | ||||||
Original Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||||
Current Study Sponsor ICMJE | Merck Sharp & Dohme LLC | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme LLC | ||||||
Verification Date | November 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |