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Trial record 22 of 50 for:    MK-2206

Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT01277757
Recruitment Status : Completed
First Posted : January 17, 2011
Results First Posted : February 12, 2016
Last Update Posted : December 18, 2018
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 Recurrent Breast Carcinoma
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Interventions Drug: Akt Inhibitor MK2206
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Enrollment 30
Recruitment Details Recruitment Period: March 14, 2011 to November 27, 2013. Recruitment done at The University of Texas MD Anderson Cancer Center, Beth-Israel Deaconness, Columbia University Medical Center, Dana Farber Cancer Center and Vanderbilt University.
Pre-assignment Details Of the 30 participants registered, two were ineligible, not treated therefore excluded from the trial outcomes.
Arm/Group Title Akt Inhibitor MK-2206
Hide Arm/Group Description Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Period Title: Overall Study
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Disease Progression             1
Withdrawal by Subject             1
Arm/Group Title Akt Inhibitor MK-2206
Hide Arm/Group Description Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Two participants were not treated.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
52.5
(31 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
30
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST)
Hide Description Number of participants with response defined by RECIST version 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame Up to 3 weeks after completion of study treatment, for up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.
Arm/Group Title Akt Inhibitor MK-2206
Hide Arm/Group Description:
Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0
Partial Response (PR) 1
Progressive Disease (PD) 20
Stable Disease (SD) 0
2.Primary Outcome
Title Number of Participants With Objective Response
Hide Description Only those participants who have measurable disease present at baseline, have received at least four doses of MK2206, and have had their disease re-evaluated will be considered evaluable for response. Response classified according the RECIST definitions, and re-evaluated for response every 12 weeks. (Note: Participants who exhibit objective disease progression prior to receiving four doses of therapy will also be considered evaluable.) In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response, and then revert to scheduled repeat imaging.
Time Frame 4 weeks following beginning treatment, repeat confirmation 4-6 weeks following response, up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.
Arm/Group Title Akt Inhibitor MK-2206
Hide Arm/Group Description:
Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
8
3.Secondary Outcome
Title 6 Month Progression-free Survival (PFS)
Hide Description Number of participants progression free at 6 months. PFS is defined as the duration of time from start of treatment, or time of progression or death, whichever occurs first. The PFS for this outcome was assessed at 6 months post treatment.
Time Frame From start of treatment to time of progression or death or six months whichever occurs first, assessed at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Akt Inhibitor MK-2206
Hide Arm/Group Description:
Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
0
4.Secondary Outcome
Title Median Response Duration
Hide Description

The duration of the response is from the time response is achieved until disease progression is detected. The duration of overall response is measured 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 (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.

Response re-evaluated every 12 weeks. In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response.

Time Frame Response assessment 4 weeks from beginning of treatment, response recorded from the start of treatment until disease progression/recurrence, up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants were not treated, and one was inevaluable.
Arm/Group Title Akt Inhibitor MK-2206
Hide Arm/Group Description:
Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Overall Number of Participants Analyzed 27
Median (Full Range)
Unit of Measure: months
5.8
(0.1 to 7.0)
5.Other Pre-specified Outcome
Title Apoptosis Assessed by Cleaved Caspase-3
Hide Description Assessment of apoptosis by immunohistochemistry to active caspase-3. Initially, the goal was to look at predictors of response, but the number of responses was not enough to make a determination.
Time Frame Up to 30 days after completion of study treatment, up to 1 year
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Cell Proliferation as Measured by the Change in Percent Ki-67 Positive Cells
Hide Description Ki-67 will be scored as % positive cells to determine whether there is a change % Ki-67+ cells before treatment versus after 2 weeks of treatment. Initially, the goal was to look at predictors of response, but the number of responses was not enough to make a determination.
Time Frame Baseline to 2 weeks
Outcome Measure Data Not Reported
Time Frame Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Akt Inhibitor MK-2206
Hide Arm/Group Description Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
All-Cause Mortality
Akt Inhibitor MK-2206
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Akt Inhibitor MK-2206
Affected / at Risk (%) # Events
Total   1/28 (3.57%)    
Blood and lymphatic system disorders   
Hematocrit drop  1  1/28 (3.57%)  1
Indicates events were collected by 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%
Akt Inhibitor MK-2206
Affected / at Risk (%) # Events
Total   24/28 (85.71%)    
Blood and lymphatic system disorders   
Examplex  1  1/28 (3.57%)  1
Activated partial thromboplastin time prolonged  1  1/28 (3.57%)  1
Anemia  1  5/28 (17.86%)  9
Cardiac disorders   
Sinus bradycardia  1  1/28 (3.57%)  1
Sinus tachycardia  1  3/28 (10.71%)  6
Eye disorders   
Blurred vision  1  3/28 (10.71%)  4
Cataract  1  1/28 (3.57%)  1
Dry eye  1  1/28 (3.57%)  1
Scleral disorder  1  1/28 (3.57%)  1
Vertigo  1  2/28 (7.14%)  2
Gastrointestinal disorders   
Abdominal pain  1  1/28 (3.57%)  1
Bloating  1  2/28 (7.14%)  3
Colonic obstruction  1  1/28 (3.57%)  1
Constipation  1  7/28 (25.00%)  9
Diarrhea  1  7/28 (25.00%)  35
Dry mouth  1  2/28 (7.14%)  4
Dyspepsia  1  4/28 (14.29%)  15
Gastritis  1  1/28 (3.57%)  1
Gastroesophageal reflux disease  1  1/28 (3.57%)  1
Mucositis oral  1  5/28 (17.86%)  12
Nausea  1  10/28 (35.71%)  30
Vomiting  1  8/28 (28.57%)  11
General disorders   
Chills  1  1/28 (3.57%)  1
Edema limbs  1  3/28 (10.71%)  4
Fatigue  1  17/28 (60.71%)  52
Fever  1  4/28 (14.29%)  4
Flu like symptoms  1  1/28 (3.57%)  2
Non-cardiac chest pain  1  1/28 (3.57%)  1
Pain  1  9/28 (32.14%)  10
Infections and infestations   
Infections and infestations - (Other)  1  2/28 (7.14%)  2
Lung infection  1  1/28 (3.57%)  1
Investigations   
Investigations - (Other)  1  1/28 (3.57%)  1
Neutrophil count decreased  1  1/28 (3.57%)  1
Platelet count decreased  1  1/28 (3.57%)  4
Weight loss  1  2/28 (7.14%)  5
White blood cell decreased  1  1/28 (3.57%)  1
Metabolism and nutrition disorders   
Alanine aminotransferase increased  1  2/28 (7.14%)  4
Alkaline phosphatase increased  1  4/28 (14.29%)  6
Anorexia  1  4/28 (14.29%)  20
Aspartate aminotransferase increased  1  5/28 (17.86%)  10
Blood bilirubin increased  1  1/28 (3.57%)  5
Creatinine increased  1  1/28 (3.57%)  1
Hyperglycemia  1  4/28 (14.29%)  7
Hypoalbuminemia  1  2/28 (7.14%)  2
Hypocalcemia  1  2/28 (7.14%)  3
Hypophosphatemia  1  1/28 (3.57%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/28 (7.14%)  2
Back pain  1  1/28 (3.57%)  1
Bone pain  1  1/28 (3.57%)  1
Muscle weakness lower limb  1  1/28 (3.57%)  1
Myalgia  1  5/28 (17.86%)  12
Pain in extremity  1  4/28 (14.29%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - (Other)  1  2/28 (7.14%)  2
Nervous system disorders   
Dizziness  1  3/28 (10.71%)  3
Headache  1  4/28 (14.29%)  5
Nervous system disorders - (Other)  1  1/28 (3.57%)  1
Paresthesia  1  6/28 (21.43%)  16
Peripheral sensory neuropathy  1  2/28 (7.14%)  2
Presyncope  1  1/28 (3.57%)  1
Syncope  1  1/28 (3.57%)  1
Psychiatric disorders   
Insomnia  1  3/28 (10.71%)  15
Reproductive system and breast disorders   
Breast pain  1  1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  6/28 (21.43%)  6
Dyspnea  1  3/28 (10.71%)  5
Hiccups  1  1/28 (3.57%)  1
Nasal congestion  1  1/28 (3.57%)  3
Postnasal drip  1  1/28 (3.57%)  1
Sore throat  1  3/28 (10.71%)  3
Skin and subcutaneous tissue disorders   
Alopecia  1  2/28 (7.14%)  2
Dry skin  1  2/28 (7.14%)  3
Nail ridging  1  1/28 (3.57%)  1
Pain of skin  1  5/28 (17.86%)  7
Palmar-plantar erythrodysesthesia syndrome  1  1/28 (3.57%)  2
Pruritus  1  5/28 (17.86%)  6
Rash maculo-papular  1  9/28 (32.14%)  38
Skin and subcutaneous tissue disorders - (Other)  1  3/28 (10.71%)  4
Vascular disorders   
Hypertension  1  2/28 (7.14%)  2
Hypotension  1  1/28 (3.57%)  1
Thromboembolic event  1  1/28 (3.57%)  1
Indicates events were collected by 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
Layout table for Results Point of Contact information
Name/Title: Funda Meric-Bernstam, MD/Chair, Investigational Cancer Therapeutics
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-563-4347
EMail: fmeric@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01277757     History of Changes
Other Study ID Numbers: NCI-2012-02892
NCI-2012-02892 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2010-0242
CDR0000694003
2010-0242 ( Other Identifier: M D Anderson Cancer Center )
8732 ( Other Identifier: CTEP )
N01CM00039 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
U01CA062490 ( U.S. NIH Grant/Contract )
First Submitted: January 13, 2011
First Posted: January 17, 2011
Results First Submitted: October 14, 2015
Results First Posted: February 12, 2016
Last Update Posted: December 18, 2018