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Trial record 7 of 50 for:    MK-2206

A Phase II Study of Akt Inhibitor MK2206 in the Treatment of Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer

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.
ClinicalTrials.gov Identifier: NCT01283035
Recruitment Status : Completed
First Posted : January 25, 2011
Results First Posted : June 24, 2016
Last Update Posted : June 24, 2016
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 Ovarian Sarcoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Drug: Akt Inhibitor MK2206
Other: Laboratory Biomarker Analysis
Enrollment 6

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 6
Completed 5
Not Completed 1
Reason Not Completed
Subject later found ineligible             1
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  60.0%
>=65 years
2
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Efficacy (as Measured by Objective Response Rate) of Akt Inhibitor MK2206 in Patients With Recurrent High-grade Platinum-resistant Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Hide Description

If 4 or more of the final set of 29 patients demonstrate a response, then the null hypothesis H0: =< 5% can be rejected in favor of the alternative hypothesis H1: >= 20% with an alpha of 0.05 and beta of 0.20 (i.e., 80% power).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression

Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Five patients started study treatment.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Stable Disease 4
Progressive Disease 1
2.Secondary Outcome
Title Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 (as Assessed by Objective Tumor Response, Progression-free Survival, and Overall Survival)
Hide Description The frequency of mutations in the PI3K/AKT and RAS pathways, copy number alterations, and PTEN loss and AKT expression as assessed by IHC will be tabulated. Associations between these markers with clinical outcome such as response rate and duration of PFS will be assessed.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Development of Feedback Loop Activation and Target Inhibition With Akt Inhibitor MK2206 Via Analysis of Pre-treatment and Post-treatment Biopsies in Select Patients Enrolled in the Trial
Hide Description [Not Specified]
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Duration of Overall Survival Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study
Hide Description Distributions will be estimated using Kaplan-Meier analysis.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Duration of Progression-free Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study
Hide Description Distributions will be estimated using Kaplan-Meier analysis.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Toxicities of Akt Inhibitor MK2206, as Assessed by the Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Hide Description [Not Specified]
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants experiencing toxicities.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
5
Time Frame Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Treatment (Akt Inhibitor MK2206)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Akt Inhibitor MK2206)
Affected / at Risk (%) # Events
Total   4/5 (80.00%)    
Gastrointestinal disorders   
Colonic Obstruction * 1  1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular * 1  4/5 (80.00%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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   5/5 (100.00%)    
Eye disorders   
Conjunctivitis * 1  1/5 (20.00%)  1
Gastrointestinal disorders   
Abdominal Pain * 1  1/5 (20.00%)  1
Chelitis * 1  1/5 (20.00%)  1
Diarrhea * 1  2/5 (40.00%)  2
Oral mucositis * 1  2/5 (40.00%)  2
Nausea * 1  1/5 (20.00%)  1
General disorders   
Fatigue * 1  3/5 (60.00%)  3
Investigations   
Increased urea * 1  1/5 (20.00%)  1
Metabolism and nutrition disorders   
Hyperglycemia * 1  1/5 (20.00%)  1
Nervous system disorders   
Dysgeusia * 1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/5 (20.00%)  1
Throat tightening * 1  1/5 (20.00%)  1
Wheezing * 1  1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome * 1  1/5 (20.00%)  1
Pruritis * 1  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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: Joyce Liu, MD, MPH
Organization: DFCI
Phone: 617-632-5269
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01283035     History of Changes
Other Study ID Numbers: NCI-2013-00549
NCI-2013-00549 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10-402 ( Other Identifier: Dana-Farber Cancer Institute )
8729 ( Other Identifier: CTEP )
P30CA006516 ( U.S. NIH Grant/Contract )
First Submitted: January 24, 2011
First Posted: January 25, 2011
Results First Submitted: February 16, 2016
Results First Posted: June 24, 2016
Last Update Posted: June 24, 2016