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Akt Inhibitor MK2206 in Treating Patients With Previously Treated Colon or Rectal Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT01802320
Recruitment Status : Completed
First Posted : March 1, 2013
Results First Posted : May 30, 2017
Last Update Posted : September 20, 2019
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 Colon Mucinous Adenocarcinoma
Colon Signet Ring Cell Adenocarcinoma
Rectal Mucinous Adenocarcinoma
Rectal Signet Ring Cell Adenocarcinoma
Recurrent Colon Carcinoma
Recurrent Rectal Carcinoma
Stage IIIA Colon Cancer
Stage IIIA Rectal Cancer
Stage IIIB Colon Cancer
Stage IIIB Rectal Cancer
Stage IIIC Colon Cancer
Stage IIIC Rectal Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Interventions Drug: Akt Inhibitor MK2206
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Enrollment 18
Recruitment Details Recruitment Period: March 07, 2013 to July 14, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 18
Completed 16
Not Completed 2
Reason Not Completed
Death             1
Withdrawal by Subject             1
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
56
(29 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  11.1%
White
13
  72.2%
More than one race
0
   0.0%
Unknown or Not Reported
2
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Overall Response Rate (CR+PR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Hide Description Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response (PR): > 30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): > 20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of >5 mm. (Note: appearance of 1/> new lesions also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:
Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Duration of Tumor Response (DR)
Hide Description Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for DR.
Time Frame From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data not collected, no analysis to be performed as participants had related tumor response.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:
Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for OS.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:
Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: months
6.8
(5.83 to 7.77)
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for PFS.
Time Frame From start of treatment to time of progression or death, whichever occurs first, assessed up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:
Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: months
1.87
(1.83 to 1.90)
5.Other Pre-specified Outcome
Title Validation of the Enrichment Biomarker Signature in Metastatic Sites
Hide Description Samples will be analyzed using the Wilcoxon rank test. Chi-square or Fisher’s exact test where appropriate will be used to determine whether high levels of marker expression correlate with PTEN status.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Given the lack of response seen in this study, biomarker validation and correlation of biomarker enrichment with clinical outcome is not feasible. Data were not collected.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:
Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data collected during active 28 day cycle, treatment may continue for up to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Akt Inhibitor MK2206)
Affected / at Risk (%)
Total   0/18 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Akt Inhibitor MK2206)
Affected / at Risk (%) # Events
Total   5/18 (27.78%)    
Cardiac disorders   
Cardiac Arrest  1  1/18 (5.56%)  1
Gastrointestinal disorders   
Small Bowel Obstruction  1  2/18 (11.11%)  3
Abdominal pain  1  1/18 (5.56%)  1
Injury, poisoning and procedural complications   
Fracture, Arm  1  1/18 (5.56%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by 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   18/18 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  6/18 (33.33%)  10
Eye disorders   
Blurred vision  1  1/18 (5.56%)  1
Conjunctivitis  1  1/18 (5.56%)  1
Eye disorders - (Other  1  1/18 (5.56%)  2
Floaters  1  1/18 (5.56%)  1
Gastrointestinal disorders   
Abdominal pain  1  2/18 (11.11%)  2
Anal pain  1  1/18 (5.56%)  1
Bloating  1  1/18 (5.56%)  1
Constipation  1  1/18 (5.56%)  1
Diarrhea  1  10/18 (55.56%)  12
Dyspepsia  1  1/18 (5.56%)  1
Hemorrhoids  1  1/18 (5.56%)  1
Nausea  1  10/18 (55.56%)  14
Small intestinal obstruction  1  2/18 (11.11%)  3
Vomiting  1  4/18 (22.22%)  6
General disorders   
Fatigue  1  7/18 (38.89%)  9
Fever  1  3/18 (16.67%)  3
Flu like symptoms  1  1/18 (5.56%)  1
Pain  1  5/18 (27.78%)  5
Infections and infestations   
Pharyngitis  1  1/18 (5.56%)  1
Upper respiratory infection  1  1/18 (5.56%)  1
Urinary tract infection  1  1/18 (5.56%)  1
Injury, poisoning and procedural complications   
Acute kidney injury  1  1/18 (5.56%)  1
Fracture  1  1/18 (5.56%)  1
Investigations   
Blood bilirubin increased  1  5/18 (27.78%)  7
Creatinine increased  1  1/18 (5.56%)  1
Lactate dehydrogenase (LDH) elevated  1  1/18 (5.56%)  1
Neutrophil count decreased  1  1/18 (5.56%)  1
Platelet count decreased  1  4/18 (22.22%)  5
Weight loss  1  4/18 (22.22%)  5
Chloride decreased  1  1/18 (5.56%)  2
Platelet increased  1  1/18 (5.56%)  1
Metabolism and nutrition disorders   
Alanine aminotransferase increased  1  1/18 (5.56%)  1
Alkaline phosphatase increased  1  7/18 (38.89%)  9
Anorexia  1  4/18 (22.22%)  6
Aspartate aminotransferase increased  1  5/18 (27.78%)  5
Dehydration  1  1/18 (5.56%)  1
Hypercalcemia  1  2/18 (11.11%)  4
Hyperglycemia  1  11/18 (61.11%)  17
Hyperkalemia  1  4/18 (22.22%)  4
Hypertriglyceridemia  1  1/18 (5.56%)  1
Hypoalbuminemia  1  2/18 (11.11%)  2
Hypocalcemia  1  2/18 (11.11%)  3
Hypokalemia  1  1/18 (5.56%)  1
Hypomagnesemia  1  1/18 (5.56%)  1
Hyponatremia  1  2/18 (11.11%)  2
Hypophosphatemia  1  1/18 (5.56%)  1
Metabolism and nutrition disorders - (Other)  1  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/18 (5.56%)  1
Flank pain  1  1/18 (5.56%)  1
Gait disturbance  1  1/18 (5.56%)  1
Muscle weakness lower limb  1  1/18 (5.56%)  1
Neck pain  1  1/18 (5.56%)  1
Pain in extremity  1  1/18 (5.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Progressive Disease  1  8/18 (44.44%)  8
Nervous system disorders   
Dysarthria  1  1/18 (5.56%)  1
Dysgeusia  1  1/18 (5.56%)  1
Headache  1  2/18 (11.11%)  2
Peripheral sensory neuropathy  1  2/18 (11.11%)  2
Psychiatric disorders   
Agitation  1  1/18 (5.56%)  1
Insomnia  1  2/18 (11.11%)  2
Renal and urinary disorders   
Blood Urea Nitrogen elevated  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/18 (5.56%)  1
Cough  1  2/18 (11.11%)  2
Dyspnea  1  3/18 (16.67%)  3
Hiccups  1  1/18 (5.56%)  1
Mucosal infection  1  1/18 (5.56%)  1
Mucositis oral  1  3/18 (16.67%)  3
Pleural effusion  1  1/18 (5.56%)  1
Sore throat  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  3/18 (16.67%)  4
Nail discoloration  1  1/18 (5.56%)  1
Nail ridging  1  1/18 (5.56%)  1
Pain of skin  1  1/18 (5.56%)  1
Rash acneiform  1  1/18 (5.56%)  1
Rash maculo-papular  1  10/18 (55.56%)  11
Skin and subcutaneous tissue disorders - (Other)  1  1/18 (5.56%)  1
Skin ulceration  1  1/18 (5.56%)  1
Vascular disorders   
Hypertension  1  1/18 (5.56%)  1
Thromboembolic event  1  1/18 (5.56%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by 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
Layout table for Results Point of Contact information
Name/Title: Dr. Scott Kopetz/Associate Professor, GI Medical Oncology
Organization: The University of Texas MD Anderson Cancer Center, Clinical Research Operations
Phone: 713-792-2828
EMail: SKopetz@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01802320     History of Changes
Other Study ID Numbers: NCI-2013-00487
NCI-2013-00487 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012-0431 ( Other Identifier: M D Anderson Cancer Center )
9340 ( Other Identifier: CTEP )
N01CM00039 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: February 27, 2013
First Posted: March 1, 2013
Results First Submitted: April 20, 2017
Results First Posted: May 30, 2017
Last Update Posted: September 20, 2019