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Trial record 16 of 50 for:    MK-2206

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

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Akt Inhibitor MK2206) PIK3CA Mutation Treatment (Akt Inhibitor MK2206) Wild Type
Hide 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
Arm/Group Title Treatment (Akt Inhibitor MK2206
Hide 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
Hide 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
37
1.Primary Outcome
Title Objective Tumor Response According to RECIST
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients who had an objective response.
Arm/Group Title Treatment (Akt Inhibitor MK2206
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients who had a PFS > 6 months.
Arm/Group Title Treatment (Akt Inhibitor MK2206
Hide 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
Hide Description Estimated by using Kaplan-Meier analysis.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Overall survival of all patients on study.
Arm/Group Title Treatment (Akt Inhibitor MK2206
Hide 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
Hide Description Estimated by using Kaplan-Meier analysis.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Akt Inhibitor MK2206) PIK3CA Mutation Treatment (Akt Inhibitor MK2206) Wild Type
Hide 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)
Hide 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]
Hide Description Data is reported in the Adverse Event table.
Time Frame 3 years
Outcome Measure Data Not Reported
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
Hide 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%)    
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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
Name/Title: Jennifer Curtis, MS
Organization: Dana-Farber Cancer Institute
Phone: 617-582-7183
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