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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01307631

First Posted: March 3, 2011

Last Update Posted: September 4, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Results First Submitted: May 23, 2017

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Recurrent Uterine Corpus Carcinoma
Interventions:	Drug: Akt Inhibitor MK2206 Other: Laboratory Biomarker Analysis

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Treatment (Akt Inhibitor MK2206) PIK3CA Mutation	Patients with PIK3CA mutation receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Treatment (Akt Inhibitor MK2206) Wild Type	Patients with wild type receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies

Description

Treatment (Akt Inhibitor MK2206) PIK3CA Mutation

Patients with PIK3CA mutation receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Treatment (Akt Inhibitor MK2206) Wild Type

Patients with wild type receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Participant Flow: Overall Study

	Treatment (Akt Inhibitor MK2206) PIK3CA Mutation	Treatment (Akt Inhibitor MK2206) Wild Type
STARTED	9	28
COMPLETED	9	28
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies

Description

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.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Baseline Measures

	Treatment (Akt Inhibitor MK2206
Overall Participants Analyzed [Units: Participants]	37

Age [Units: Participants] Count of Participants
<=18 years	0 0.0%
Between 18 and 65 years	26 70.3%
>=65 years	11 29.7%

Age [Units: Years] Median (Full Range)	56 (39 to 73)

Sex: Female, Male [Units: Participants] Count of Participants
Female	37 100.0%
Male	0 0.0%

Region of Enrollment [Units: Participants]
United States	37

Outcome Measures

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1. Primary:

Objective Tumor Response According to RECIST [ Time Frame: Up to 6 months ]

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2. Primary:

Progression-free Survival According to RECIST [ Time Frame: From start of treatment to time of objective disease progression, assessed up to 6 months ]

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3. Secondary:

Duration of Overall Survival [ Time Frame: Up to 3 years ]

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4. Secondary:

Duration of Progression-free Survival [ Time Frame: Up to 3 years ]

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5. Other Pre-specified:

Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 Such as Progression-free Survival and Objective Tumor Response, Assessed by Immunohistochemistry (IHC) [ Time Frame: Up to 3 years ]

Results not yet reported. Anticipated Reporting Date: No text entered.

6. Other Pre-specified:

Incidence of Adverse Events as Assessed by NCI CTCAE Version 4.0 [Time Frame: Up to 3 Years] [Designated as Safety Issue: Yes] [ Time Frame: 3 years ]

Results not yet reported. Anticipated Reporting Date: No text entered.

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Jennifer Curtis, MS
Organization: Dana-Farber Cancer Institute
phone: 617-582-7183
e-mail: jennifer_curtis@dfci.harvard.edu

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01307631 History of Changes
Obsolete Identifiers:	NCT01312753
Other Study ID Numbers:	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 )
First Submitted:	March 1, 2011
First Posted:	March 3, 2011
Results First Submitted:	May 23, 2017
Results First Posted:	September 4, 2017
Last Update Posted:	September 4, 2017

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