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

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

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
Enrollment	37

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Treatment (Akt Inhibitor MK2206) PIK3CA Mutation	Treatment (Akt Inhibitor MK2206) Wild Type
Arm/Group Description	Patients with PIK3CA mutation recei...	Patients with wild type receive Akt...
Arm/Group Description	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	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
Period Title: Overall Study
Started	9	28
Completed	9	28
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Treatment (Akt Inhibitor MK2206
Arm/Group Description		Patients receive Akt inhibitor MK22...
Arm/Group Description		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
Overall Number of Baseline Participants		37
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	37 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	26 70.3%
	>=65 years	11 29.7%
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	37 participants
		56 (39 to 73)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	37 participants
	Female	37 100.0%
	Male	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	37 participants
United States		37

Outcome Measures

1.Primary Outcome


Title	Objective Tumor Response According to RECIST
Description	Activity will be ascertained by the proportion of patients who survive...
Description	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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

Number of patients who had an objective response.


Arm/Group Title	Treatment (Akt Inhibitor MK2206
Arm/Group Description:	Patients receive Akt inhibitor MK22...
Arm/Group Description:	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
Overall Number of Participants Analyzed	37
Measure Type: Count of Participants Unit of Measure: Participants
	2 5.4%

2.Primary Outcome


Title	Progression-free Survival According to RECIST
Description	Activity will be ascertained by the proportion of patients who survive...
Description	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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame	From start of treatment to time of objective disease progression, assessed up to 6 months

Outcome Measure Data

Analysis Population Description

Number of patients who had a PFS > 6 months.


Arm/Group Title	Treatment (Akt Inhibitor MK2206
Arm/Group Description:	Patients receive Akt inhibitor MK22...
Arm/Group Description:	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
Overall Number of Participants Analyzed	37
Measure Type: Count of Participants Unit of Measure: Participants
	4 10.8%

3.Secondary Outcome


Title	Duration of Overall Survival
Description	Estimated by using Kaplan-Meier analysis.
Description	Estimated by using Kaplan-Meier analysis.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Overall survival of all patients on study.


Arm/Group Title	Treatment (Akt Inhibitor MK2206
Arm/Group Description:	Patients receive Akt inhibitor MK22...
Arm/Group Description:	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
Overall Number of Participants Analyzed	37
Median (Full Range) Unit of Measure: months
	8 (0 to 12)

4.Secondary Outcome


Title	Duration of Progression-free Survival
Description	Estimated by using Kaplan-Meier analysis.
Description	Estimated by using Kaplan-Meier analysis.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Treatment (Akt Inhibitor MK2206) PIK3CA Mutation	Treatment (Akt Inhibitor MK2206) Wild Type
Arm/Group Description:	Patients with PIK3CA mutation recei...	Patients with wild type receive Akt...
Arm/Group Description:	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	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
Overall Number of Participants Analyzed	9	28
Median (90% Confidence Interval) Unit of Measure: months
	1.6 (0 to 1.6)	1.8 (0 to 1.8)

5.Other Pre-specified Outcome


Title	Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 Such as Progression-free Survival and Objective Tumor Response, Assessed by Immunohistochemistry (IHC)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

6.Other Pre-specified Outcome


Title	Incidence of Adverse Events as Assessed by NCI CTCAE Version 4.0 [Time Frame: Up to 3 Years] [Designated as Safety Issue: Yes]
Description	Data is reported in the Adverse Event table.
Description	Data is reported in the Adverse Event table.
Time Frame	3 years

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Treatment (Akt Inhibitor MK2206
Arm/Group Description	Patients receive Akt inhibitor MK22...
Arm/Group Description	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
All-Cause Mortality
	Treatment (Akt Inhibitor MK2206
	Affected / at Risk (%)
Total	0/37 (0.00%)
Serious Adverse Events Serious Adverse Events
	Treatment (Akt Inhibitor MK2206
	Affected / at Risk (%)	# Events
Total	14/37 (37.84%)
Blood and lymphatic system disorders
Thromboembolic event ^* 1	4/37 (10.81%)	4
General disorders
Hyperglycemia ^* 1	2/37 (5.41%)	2
Fever ^* 1	1/37 (2.70%)	1
Skin and subcutaneous tissue disorders
Rash ^* 1	7/37 (18.92%)	7
1 Term from vocabulary, CTCAE (4.0) * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Treatment (Akt Inhibitor MK2206
	Affected / at Risk (%)	# Events
Total	15/37 (40.54%)
Blood and lymphatic system disorders
anemia ^* 1	2/37 (5.41%)	5
Gastrointestinal disorders
abdominal pain ^* 1	4/37 (10.81%)	5
constipation ^* 1	5/37 (13.51%)	6
diarrhea ^* 1	6/37 (16.22%)	8
nausea ^* 1	5/37 (13.51%)	5
vomiting ^* 1	3/37 (8.11%)	3
General disorders
edema limbs ^* 1	5/37 (13.51%)	5
fatigue ^* 1	11/37 (29.73%)	13
non-cardiac chest pain ^* 1	1/37 (2.70%)	1
Infections and infestations
urinary tract infections ^* 1	2/37 (5.41%)	2
Injury, poisoning and procedural complications
bruising ^* 1	1/37 (2.70%)	1
Investigations
creatinine decreased ^* 1	1/37 (2.70%)	1
weight loss ^* 1	1/37 (2.70%)	1
creatinine increased ^* 1	1/37 (2.70%)	2
Metabolism and nutrition disorders
anorexia ^* 1	3/37 (8.11%)	3
hyponatremia ^* 1	1/37 (2.70%)	2
hypomagnesemia ^* 1	3/37 (8.11%)	3
hyperglycemia ^* 1	4/37 (10.81%)	4
Musculoskeletal and connective tissue disorders
arthralgia ^* 1	1/37 (2.70%)	1
back pain ^* 1	3/37 (8.11%)	4
bone pain ^* 1	2/37 (5.41%)	4
Nervous system disorders
peripheral sensory neuropathy ^* 1	6/37 (16.22%)	6
ataxia ^* 1	1/37 (2.70%)	1
Psychiatric disorders
anxiety ^* 1	1/37 (2.70%)	1
insomnia ^* 1	1/37 (2.70%)	1
Renal and urinary disorders
Acute kdiney injury ^* 1	2/37 (5.41%)	2
urinary frequency ^* 1	1/37 (2.70%)	2
hematuria ^* 1	1/37 (2.70%)	1
Reproductive system and breast disorders
pelvic pain ^* 1	2/37 (5.41%)	2
vaginal hemorrhage ^* 1	1/37 (2.70%)	1
Respiratory, thoracic and mediastinal disorders
pleuritic pain ^* 1	1/37 (2.70%)	1
cough ^* 1	1/37 (2.70%)	1
Skin and subcutaneous tissue disorders
skin ulceration ^* 1	1/37 (2.70%)	1
nail discoloration ^* 1	1/37 (2.70%)	1
Vascular disorders
hot flashes ^* 1	1/37 (2.70%)	1
1 Term from vocabulary, CTCAE (4.0) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

Layout table for Results Point of Contact information

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

Layout table for additonal information

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 5, 2017
Last Update Posted:	September 5, 2017

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