Trial Outcomes & Findings for MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer (NCT NCT01319539)
NCT ID: NCT01319539
Last Updated: 2017-08-30
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline, 2 weeks (Day 0 - surgery)
Results posted on
2017-08-30
Participant Flow
12 participants were enrolled between September 2011 and March 2013.
Participant milestones
| Measure |
Treatment (Akt Inhibitor MK2206)
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 Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Akt Inhibitor MK2206)
n=12 Participants
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
|
|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks (Day 0 - surgery)Population: Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.
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).
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=7 Participants
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
|
|---|---|
|
Change in pAKT Levels
Core
|
25 percentage of cells
Standard Deviation 29
|
|
Change in pAKT Levels
Surgery
|
0 percentage of cells
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks (Day 0 - surgery)Population: Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.
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).
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=7 Participants
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
|
|---|---|
|
Change in pS6 Levels
Core
|
41 percentage of cells
Standard Deviation 36
|
|
Change in pS6 Levels
Surgery
|
31 percentage of cells
Standard Deviation 32
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks (Day 0 - surgery)Population: Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.
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).
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=7 Participants
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
|
|---|---|
|
Change in Ki-67 Expression
Core
|
13 percentage of cells
Standard Deviation 23
|
|
Change in Ki-67 Expression
Surgery
|
12 percentage of cells
Standard Deviation 23
|
Adverse Events
Treatment (MK2206) Dose Level 200mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment (MK2206) Dose Level 135mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment (MK2206) Dose Level 90mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (MK2206) Dose Level 200mg
n=4 participants at risk
Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
|
Treatment (MK2206) Dose Level 135mg
n=3 participants at risk
Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
|
Treatment (MK2206) Dose Level 90mg
n=5 participants at risk
Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
|
|---|---|---|---|
|
General disorders
Fever
|
25.0%
1/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Rash, Grade 3
|
0.00%
0/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
20.0%
1/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
Other adverse events
| Measure |
Treatment (MK2206) Dose Level 200mg
n=4 participants at risk
Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
|
Treatment (MK2206) Dose Level 135mg
n=3 participants at risk
Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
|
Treatment (MK2206) Dose Level 90mg
n=5 participants at risk
Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
|
|---|---|---|---|
|
Gastrointestinal disorders
Mucositis, Grade 1
|
25.0%
1/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
20.0%
1/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Mucositis, Grade 2
|
50.0%
2/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
20.0%
1/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Rash, Grade 2
|
25.0%
1/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Rash, Grade 3
|
25.0%
1/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
66.7%
2/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
20.0%
1/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Pruritus, Grade 1
|
0.00%
0/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
33.3%
1/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Pruritus, Grade 3
|
50.0%
2/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
33.3%
1/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
2/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
20.0%
1/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
|
General disorders
Fever
|
25.0%
1/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/4 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
0.00%
0/3 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
40.0%
2/5 • 2 weeks
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60