Clinical Trial: Akt Inhibitor MK2206 in Treating Patients With Recurrent or Advanced Endometrial Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Summary:

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 toxi
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Objective tumor response according to RECIST [ Time Frame: Up to 6 months ]
  • Progression-free survival according to RECIST [ Time Frame: From start of treatment to time of objective disease progression, assessed up to 6 months ]


Original Primary Outcome:

  • Progression-free survival for at least 6 months after initiating therapy
  • Objective tumor response


Current Secondary Outcome:

  • Duration of overall survival [ Time Frame: Up to 3 years ]
    Estimated by using Kaplan-Meier analysis.
  • Duration of progression-free survival [ Time Frame: Up to 3 years ]
    Estimated by using Kaplan-Meier analysis.
  • Incidence of adverse events as assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ]


Original Secondary Outcome:

  • Duration of progression-free and overall survival following initiation of therapy with MK-2206
  • Toxicity as assessed by NCI NTCAE v. 4


Information By: National Cancer Institute (NCI)

Dates:
Date Received: March 1, 2011
Date Started: March 2011
Date Completion:
Last Updated: December 30, 2016
Last Verified: December 2016