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Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma

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ClinicalTrials.gov Identifier: NCT01604772
Recruitment Status : Completed
First Posted : May 24, 2012
Results First Posted : June 26, 2015
Last Update Posted : April 20, 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 Oral Cavity Adenoid Cystic Carcinoma
Recurrent Salivary Gland Carcinoma
Salivary Gland Adenoid Cystic Carcinoma
Stage IVA Major Salivary Gland Cancer AJCC v7
Stage IVA Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
Stage IVB Major Salivary Gland Cancer AJCC v7
Stage IVB Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
Stage IVC Major Salivary Gland Cancer AJCC v7
Stage IVC Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
Interventions Drug: Akt Inhibitor MK2206
Other: Laboratory Biomarker Analysis
Enrollment 16

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: 150 mg given PO

Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: 150 mg given PO

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
63.5
(31 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
10
  62.5%
Male
6
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Confirmed Response Rate (Complete Response + Partial Response) According to RECIST Version 1.1
Hide Description

Confirmed response rate will be reported as the number of participants achieving either a complete response or partial response (using RECIST v1.1) divided by the number of evaluable participants. In order for a participant to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart.

Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.

Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Time Frame Up to 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two patients were deemed ineligible for this endpoint due to eligibility criteria not being met. Therefore, this endpoint is reported using 14 eligible patients.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0
(0 to 23.2)
2.Secondary Outcome
Title Median Progression Free Survival
Hide Description Progression Free Survival is defined as the time from registration to the earliest date of documentation of disease progression or death. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time Frame Time of study entry to progression or death, up to 3 years after registration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two patients were deemed ineligible and were not included in this endpoint.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: 150 mg given PO

Overall Number of Participants Analyzed 14
Median (95% Confidence Interval)
Unit of Measure: months
9.2
(3.8 to 11.0)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival is defined as the time from registration to death. The distribution of survival will be estimated using the method of Kaplan-MeierEstimated using Kaplan-Meier methodology.
Time Frame Time of study entry to death due to any cause, assessed up to 3 years from registration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This endpoint has not been assessed yet.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: 150 mg given PO

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Incidence of Toxicities of Akt Inhibitor MK-2206
Hide Description Safety will be assessed in terms of the number of participants reporting grade 3 or higher adverse events as evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Time Frame Time to first treatment to up to 30 days after completion of treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: 150 mg given PO

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   2/16 (12.50%)    
Gastrointestinal disorders   
Esophageal hemorrhage  1  1/16 (6.25%)  1
Nausea  1  1/16 (6.25%)  1
Vomiting  1  1/16 (6.25%)  1
Infections and infestations   
Urinary tract infection  1  1/16 (6.25%)  1
Investigations   
Creatinine increased  1  1/16 (6.25%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/16 (6.25%)  1
Vascular disorders   
Hypotension  1  1/16 (6.25%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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   16/16 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  3/16 (18.75%)  12
Blood and lymphatic system disorders - Other, specify  1  6/16 (37.50%)  14
Cardiac disorders   
Sinus bradycardia  1  1/16 (6.25%)  1
Eye disorders   
Cataract  1  1/16 (6.25%)  1
Dry eye  1  1/16 (6.25%)  3
Eye disorders - Other, specify  1  1/16 (6.25%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/16 (6.25%)  2
Cheilitis  1  1/16 (6.25%)  10
Constipation  1  2/16 (12.50%)  10
Diarrhea  1  4/16 (25.00%)  10
Dry mouth  1  2/16 (12.50%)  2
Dyspepsia  1  1/16 (6.25%)  2
Dysphagia  1  1/16 (6.25%)  1
Mucositis oral  1  3/16 (18.75%)  4
Nausea  1  4/16 (25.00%)  6
Oral pain  1  1/16 (6.25%)  2
Vomiting  1  1/16 (6.25%)  1
General disorders   
Edema limbs  1  1/16 (6.25%)  1
Fatigue  1  13/16 (81.25%)  38
Pain  1  2/16 (12.50%)  3
Infections and infestations   
Bronchial infection  1  1/16 (6.25%)  1
Lung infection  1  1/16 (6.25%)  1
Skin infection  1  1/16 (6.25%)  1
Upper respiratory infection  1  2/16 (12.50%)  3
Injury, poisoning and procedural complications   
Fall  1  1/16 (6.25%)  3
Investigations   
Alanine aminotransferase increased  1  2/16 (12.50%)  6
Alkaline phosphatase increased  1  2/16 (12.50%)  11
Aspartate aminotransferase increased  1  1/16 (6.25%)  3
Creatinine increased  1  1/16 (6.25%)  1
Electrocardiogram QT corrected interval prolonged  1  2/16 (12.50%)  2
Investigations - Other, specify  1  1/16 (6.25%)  4
Lymphocyte count decreased  1  7/16 (43.75%)  12
Neutrophil count decreased  1  1/16 (6.25%)  1
Platelet count decreased  1  7/16 (43.75%)  29
Weight loss  1  5/16 (31.25%)  22
White blood cell decreased  1  1/16 (6.25%)  10
Metabolism and nutrition disorders   
Anorexia  1  6/16 (37.50%)  15
Dehydration  1  1/16 (6.25%)  1
Hyperglycemia  1  14/16 (87.50%)  51
Hyperkalemia  1  2/16 (12.50%)  5
Hypernatremia  1  2/16 (12.50%)  3
Hyperuricemia  1  1/16 (6.25%)  1
Hypocalcemia  1  3/16 (18.75%)  6
Hypomagnesemia  1  1/16 (6.25%)  1
Hypophosphatemia  1  4/16 (25.00%)  5
Musculoskeletal and connective tissue disorders   
Neck pain  1  1/16 (6.25%)  10
Pain in extremity  1  2/16 (12.50%)  3
Nervous system disorders   
Dysgeusia  1  2/16 (12.50%)  8
Headache  1  2/16 (12.50%)  10
Memory impairment  1  1/16 (6.25%)  1
Peripheral sensory neuropathy  1  1/16 (6.25%)  10
Psychiatric disorders   
Anxiety  1  1/16 (6.25%)  1
Confusion  1  1/16 (6.25%)  1
Insomnia  1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/16 (6.25%)  2
Cough  1  4/16 (25.00%)  5
Dyspnea  1  3/16 (18.75%)  6
Nasal congestion  1  1/16 (6.25%)  1
Productive cough  1  1/16 (6.25%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  1/16 (6.25%)  3
Dry skin  1  4/16 (25.00%)  6
Palmar-plantar erythrodysesthesia syndrome  1  1/16 (6.25%)  1
Pruritus  1  6/16 (37.50%)  10
Purpura  1  1/16 (6.25%)  6
Rash maculo-papular  1  13/16 (81.25%)  58
Skin and subcutaneous tissue disorders - Other, specify  1  2/16 (12.50%)  13
Vascular disorders   
Hypertension  1  1/16 (6.25%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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
Name/Title: Alan Ho, M.D.
Organization: Memorial Sloan Kettering Cancer Center
EMail: hoa@mskcc.org
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01604772     History of Changes
Other Study ID Numbers: NCI-2012-01966
NCI-2012-01966 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000733948
CALGB-A091104
A091104 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A091104 ( Other Identifier: CTEP )
N01CM62206 ( U.S. NIH Grant/Contract )
R01CA166978 ( U.S. NIH Grant/Contract )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: May 22, 2012
First Posted: May 24, 2012
Results First Submitted: June 4, 2015
Results First Posted: June 26, 2015
Last Update Posted: April 20, 2018