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Trial record 21 of 50 for:    MK-2206

MK2206 in Treating Patients With Advanced Liver Cancer That Did Not Respond to Previous Therapy

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ClinicalTrials.gov Identifier: NCT01239355
Recruitment Status : Terminated (Early termination for discouraging results)
First Posted : November 11, 2010
Results First Posted : October 5, 2015
Last Update Posted : October 5, 2015
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 Adult Hepatocellular Carcinoma
Advanced Adult Hepatocellular Carcinoma
Localized Non-Resectable Adult Liver Carcinoma
Recurrent Adult Liver Carcinoma
Interventions Drug: Akt Inhibitor MK2206
Other: Laboratory Biomarker Analysis
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. 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 15
Completed 15
Not Completed 0
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. 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 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
65
(50 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
3
  20.0%
Male
12
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Progression-free Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Until disease progression or death, up to 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. 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 15
Median (95% Confidence Interval)
Unit of Measure: Months
1.7
(1.6 to 3.0)
2.Secondary Outcome
Title Objective Response
Hide Description 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; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR
Time Frame Evaluated for response every 2 cycles (8 weeks) with confirmatory evaluation at least 4 weeks following initial documentation of objective response, up to 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. 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 15
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Overall Survival
Hide Description Survival will be estimated by the product-limit (Kaplan-Meier) estimator.
Time Frame Until death, up to 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. 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 15
Median (95% Confidence Interval)
Unit of Measure: Months
6.1
(3.0 to 8.4)
Time Frame Adverse events recorded over a period of 1 year and 5 months.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. 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   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Akt Inhibitor MK2206)
Affected / at Risk (%) # Events
Total   6/15 (40.00%)    
Gastrointestinal disorders   
Ascites *  1/15 (6.67%)  1
Mucositis oral *  1/15 (6.67%)  1
Oral pain *  1/15 (6.67%)  1
General disorders   
Fever *  1/15 (6.67%)  1
Pain *  1/15 (6.67%)  1
Investigations   
Alanine aminotransferase increased *  1/15 (6.67%)  1
Aspartate aminotransferase increased *  1/15 (6.67%)  1
Blood bilirubin increased *  2/15 (13.33%)  2
Neutrophil count decreased *  1/15 (6.67%)  1
White blood cell decreased *  1/15 (6.67%)  1
Metabolism and nutrition disorders   
Hyponatremia *  2/15 (13.33%)  2
Musculoskeletal and connective tissue disorders   
Bone pain *  1/15 (6.67%)  1
Nervous system disorders   
Movements involuntary *  1/15 (6.67%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea *  1/15 (6.67%)  1
*
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   15/15 (100.00%)    
Blood and lymphatic system disorders   
Anemia *  11/15 (73.33%)  17
Cardiac disorders   
Sinus tachycardia *  1/15 (6.67%)  1
Gastrointestinal disorders   
Abdominal distension *  1/15 (6.67%)  1
Abdominal pain *  1/15 (6.67%)  2
Bloating *  1/15 (6.67%)  1
Constipation *  4/15 (26.67%)  6
Diarrhea *  6/15 (40.00%)  6
Dry mouth *  5/15 (33.33%)  6
Gastrointestinal pain *  1/15 (6.67%)  3
Mucositis oral *  3/15 (20.00%)  3
Nausea *  3/15 (20.00%)  4
Rectal hemorrhage *  1/15 (6.67%)  1
Stomach pain *  1/15 (6.67%)  1
Toothache *  1/15 (6.67%)  1
Vomiting *  1/15 (6.67%)  1
General disorders   
Chills *  1/15 (6.67%)  1
Edema limbs *  2/15 (13.33%)  2
Edema trunk *  1/15 (6.67%)  1
Fatigue *  9/15 (60.00%)  14
Fever *  2/15 (13.33%)  3
Flu like symptoms *  2/15 (13.33%)  2
Pain *  2/15 (13.33%)  2
Infections and infestations   
Mucosal infection *  1/15 (6.67%)  1
Investigations   
Activated partial thromboplastin time pr *  1/15 (6.67%)  1
Alanine aminotransferase increased *  7/15 (46.67%)  14
Alkaline phosphatase increased *  8/15 (53.33%)  21
Aspartate aminotransferase increased *  11/15 (73.33%)  26
Blood bilirubin increased *  3/15 (20.00%)  11
Creatinine increased *  3/15 (20.00%)  3
Electrocardiogram QT corrected interval *  3/15 (20.00%)  6
INR increased *  1/15 (6.67%)  1
Lymphocyte count decreased *  3/15 (20.00%)  7
Neutrophil count decreased *  4/15 (26.67%)  6
Platelet count decreased *  6/15 (40.00%)  17
Weight gain *  1/15 (6.67%)  1
White blood cell decreased *  3/15 (20.00%)  11
Metabolism and nutrition disorders   
Anorexia *  4/15 (26.67%)  5
Hypercalcemia *  1/15 (6.67%)  1
Hyperglycemia *  9/15 (60.00%)  19
Hyperkalemia *  2/15 (13.33%)  2
Hypoalbuminemia *  7/15 (46.67%)  10
Hypokalemia *  1/15 (6.67%)  1
Hyponatremia *  1/15 (6.67%)  1
Hypophosphatemia *  3/15 (20.00%)  4
Musculoskeletal and connective tissue disorders   
Back pain *  1/15 (6.67%)  4
Flank pain *  1/15 (6.67%)  4
Generalized muscle weakness *  1/15 (6.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain *  1/15 (6.67%)  1
Nervous system disorders   
Dysgeusia *  1/15 (6.67%)  2
Headache *  2/15 (13.33%)  4
Presyncope *  1/15 (6.67%)  1
Somnolence *  1/15 (6.67%)  1
Psychiatric disorders   
Depression *  1/15 (6.67%)  1
Insomnia *  1/15 (6.67%)  1
Renal and urinary disorders   
Urinary tract obstruction *  1/15 (6.67%)  1
Urine discoloration *  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis *  1/15 (6.67%)  2
Cough *  1/15 (6.67%)  1
Dyspnea *  2/15 (13.33%)  2
Pleuritic pain *  1/15 (6.67%)  2
Skin and subcutaneous tissue disorders   
Alopecia *  1/15 (6.67%)  1
Dry skin *  3/15 (20.00%)  3
Periorbital edema *  1/15 (6.67%)  1
Pruritus *  4/15 (26.67%)  11
Rash maculo-papular *  5/15 (33.33%)  12
Vascular disorders   
Hypertension *  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results
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: DCC Project Administrator
Organization: California Cancer Consortium
Phone: 626-256-4673 ext 60094
EMail: CCCP@coh.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01239355     History of Changes
Other Study ID Numbers: NCI-2011-02549
NCI-2011-02549 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000688549
CHNMC-PHII-105
PHII-105 ( Other Identifier: City of Hope Comprehensive Cancer Center )
8752 ( Other Identifier: CTEP )
P30CA033572 ( U.S. NIH Grant/Contract )
N01CM00038 ( U.S. NIH Grant/Contract )
First Submitted: November 10, 2010
First Posted: November 11, 2010
Results First Submitted: June 10, 2015
Results First Posted: October 5, 2015
Last Update Posted: October 5, 2015