Akt Inhibitor MK2206 in Treating Patients With Recurrent or Advanced Endometrial Cancer
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ClinicalTrials.gov Identifier: NCT01307631 |
Recruitment Status
:
Completed
First Posted
: March 3, 2011
Results First Posted
: September 5, 2017
Last Update Posted
: September 5, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | March 1, 2011 | |||
First Posted Date ICMJE | March 3, 2011 | |||
Results First Submitted Date | May 23, 2017 | |||
Results First Posted Date | September 5, 2017 | |||
Last Update Posted Date | September 5, 2017 | |||
Actual Study Start Date ICMJE | March 2011 | |||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01307631 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE |
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Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Akt Inhibitor MK2206 in Treating Patients With Recurrent or Advanced Endometrial Cancer | |||
Official Title ICMJE | A Phase II, 2-Stage, 2-Arm PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer | |||
Brief Summary | This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with recurrent or advanced endometrial cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. | |||
Detailed Description | PRIMARY OBJECTIVES: I. To assess the activity of MK-2206 (Akt inhibitor MK2206) in patients with recurrent or persistent endometrial cancer classified by phosphoinositide-3-kinase catalytic alpha (PIK3CA) mutation. Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. II. To evaluate the efficacy of MK2206 in patients with serous tumors using a composite endpoint of complete and partial response by Response Evaluation Criteria In Solid Tumors (RECIST) and progression-free interval of 6 months or longer. SECONDARY OBJECTIVES: I. To determine the duration of progression-free survival and overall survival. II. To determine the nature and degree of toxicity of MK-2206 as assessed by version 4 of the National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events (CTCAE) in these cohorts of patients. III. To explore the associations between select biomarkers and response to MK-2206 such as progression-free survival, objective tumor response, and overall survival as well as patient characteristics such as histological cell type. IV. To explore the development of feed-back loop activation (post-treatment biopsy biomarker analysis) and target inhibition using MK-2206 via analysis of pre-treatment and post-treatment biopsies in select patients enrolled in the trial. V. To determine the duration of progression-free and overall survival, following initiation of therapy with MK-2206. VI. To determine the toxicities of MK-2206, as assessed with the revised NCI CTCAE version 4. VII. To explore the association between select biomarkers and response to MK-2206 such as progression-free survival, objective tumor response. OUTLINE: Patients receive Akt inhibitor MK2206 orally (PO) once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms | Experimental: Treatment (Akt inhibitor MK2206
Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions:
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Publications * | Not Provided | |||
* 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 |
37 | |||
Original Estimated Enrollment ICMJE |
90 | |||
Actual Study Completion Date | June 30, 2017 | |||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01307631 | |||
Other Study ID Numbers ICMJE | NCI-2013-00521 NCI-2013-00521 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 10.258 10-258 ( Other Identifier: Dana-Farber Cancer Institute ) 8760 ( Other Identifier: CTEP ) P30CA006516 ( U.S. NIH Grant/Contract ) U01CA062490 ( U.S. NIH Grant/Contract ) UM1CA186709 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | National Cancer Institute (NCI) | |||
Study Sponsor ICMJE | National Cancer Institute (NCI) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | August 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |