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Trial record 15 of 50 for:    MK-2206

MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

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ClinicalTrials.gov Identifier: NCT01319539
Recruitment Status : Terminated (terminated early, due to toxicity)
First Posted : March 21, 2011
Results First Posted : August 1, 2017
Last Update Posted : August 30, 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 Estrogen Receptor Negative
Estrogen Receptor Positive
HER2/Neu Negative
HER2/Neu Positive
Progesterone Receptor Negative
Progesterone Receptor Positive
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Triple-Negative Breast Carcinoma
Interventions Drug: Akt Inhibitor MK2206
Procedure: Therapeutic Conventional Surgery
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis
Enrollment 12
Recruitment Details 12 participants were enrolled between September 2011 and March 2013.
Pre-assignment Details  
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.

Akt Inhibitor MK2206: Given PO

Therapeutic Conventional Surgery: Undergo surgery

Pharmacological Study: Correlative studies

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.

Akt Inhibitor MK2206: Given PO

Therapeutic Conventional Surgery: Undergo surgery

Pharmacological Study: Correlative studies

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
53.2  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic
7
  58.3%
Non-Hispanic White
4
  33.3%
Non-Hispanic Black
1
   8.3%
Asian
0
   0.0%
1.Primary Outcome
Title Change in pAKT Levels
Hide Description This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).
Time Frame Baseline, 2 weeks (Day 0 - surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.

Akt Inhibitor MK2206: Given PO

Therapeutic Conventional Surgery: Undergo surgery

Pharmacological Study: Correlative studies

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: percentage of cells
Core 25  (29)
Surgery 0  (0)
2.Secondary Outcome
Title Change in pS6 Levels
Hide Description This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).
Time Frame Baseline, 2 weeks (Day 0 - surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.

Akt Inhibitor MK2206: Given PO

Therapeutic Conventional Surgery: Undergo surgery

Pharmacological Study: Correlative studies

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: percentage of cells
Core 41  (36)
Surgery 31  (32)
3.Secondary Outcome
Title Change in Ki-67 Expression
Hide Description This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).
Time Frame Baseline, 2 weeks (Day 0 - surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.

Akt Inhibitor MK2206: Given PO

Therapeutic Conventional Surgery: Undergo surgery

Pharmacological Study: Correlative studies

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: percentage of cells
Core 13  (23)
Surgery 12  (23)
Time Frame 2 weeks
Adverse Event Reporting Description The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
 
Arm/Group Title Treatment (MK2206) Dose Level 200mg Treatment (MK2206) Dose Level 135mg Treatment (MK2206) Dose Level 90mg
Hide Arm/Group Description Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0. Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0. Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
All-Cause Mortality
Treatment (MK2206) Dose Level 200mg Treatment (MK2206) Dose Level 135mg Treatment (MK2206) Dose Level 90mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (MK2206) Dose Level 200mg Treatment (MK2206) Dose Level 135mg Treatment (MK2206) Dose Level 90mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   0/3 (0.00%)   1/5 (20.00%) 
General disorders       
Fever * [1]  1/4 (25.00%)  0/3 (0.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash, Grade 3 *  0/4 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Participant also experienced Rash
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (MK2206) Dose Level 200mg Treatment (MK2206) Dose Level 135mg Treatment (MK2206) Dose Level 90mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   3/3 (100.00%)   5/5 (100.00%) 
Gastrointestinal disorders       
Mucositis, Grade 1 *  1/4 (25.00%)  0/3 (0.00%)  1/5 (20.00%) 
Mucositis, Grade 2 *  2/4 (50.00%)  0/3 (0.00%)  1/5 (20.00%) 
General disorders       
Fever *  1/4 (25.00%)  0/3 (0.00%)  0/5 (0.00%) 
Metabolism and nutrition disorders       
Hyperglycemia *  2/4 (50.00%)  0/3 (0.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders       
Rash, Grade 2 *  1/4 (25.00%)  0/3 (0.00%)  0/5 (0.00%) 
Rash, Grade 3 *  1/4 (25.00%)  2/3 (66.67%)  1/5 (20.00%) 
Pruritus, Grade 1 *  0/4 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Pruritus, Grade 3 *  2/4 (50.00%)  1/3 (33.33%)  0/5 (0.00%) 
Dry Skin *  0/4 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
*
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
Layout table for Results Point of Contact information
Name/Title: Kevin Kalinsky, MD
Organization: Columbia University Medical Center
Phone: 212-305-1945
EMail: kk2693@cumc.columbia.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01319539     History of Changes
Other Study ID Numbers: NCI-2011-02513
NCI-2011-02513 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000696821 ( Other Identifier: NCI )
AECM-AAAF3912 ( Other Identifier: Montefiore Medical Center - Moses Campus )
8740 ( Other Identifier: CTEP )
N01CM62204 ( U.S. NIH Grant/Contract )
P30CA013330 ( U.S. NIH Grant/Contract )
First Submitted: March 18, 2011
First Posted: March 21, 2011
Results First Submitted: October 14, 2016
Results First Posted: August 1, 2017
Last Update Posted: August 30, 2017