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Trial record 16 of 50 for:    MK-2206

Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01349933
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : January 8, 2015
Last Update Posted : December 5, 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 Recurrent Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Intervention Drug: Akt inhibitor MK2206
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Akt Inhibitor MK2206)
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Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt inhibitor MK2206: Given PO

Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description

Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt inhibitor MK2206: Given PO

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
47
(32 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
2
   9.5%
Male
19
  90.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants
Singapore 9
Hong Kong 12
1.Primary Outcome
Title Proportion of Patients Alive and Progression-free
Hide Description The primary endpoint of this trial is the proportion of patients alive and progression-free at 6 months. Progression status is evaluated using RECIST version 1.1. A Progression is defined as either: At least one new malignant lesion, which also includes any lymph node that was normal at baseline (less than 1.0 cm short axis) and increased to greater than or equal to 1 cm short axis during follow up. Or, at least a 20% increase in sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes.
Time Frame 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Akt Inhibitor MK2206)
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Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt inhibitor MK2206: Given PO

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
Alive and Progression Free 9
Dead or Progression 12
2.Primary Outcome
Title Confirmed Response Rate Defined to be a CR or PR Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart
Hide Description Evaluated using RECIST version 1.1. A Complete Response (CR) requires disappearance of all target lesions and each target lymph node must have reduction in short axis to <1.0 cm. A Partial Response (PR) requires at least a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt inhibitor MK2206: Given PO

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response 0
Partial Response 4.8
3.Secondary Outcome
Title Adverse Events Associated With the Agent Graded Based on CTCAE Version 4.0
Hide Description The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. Only the severe or worse adverse events will be assessed, regardless of relationship to the study treatment. The number of patients reporting a grade 3 or higher event were counted.
Time Frame Up to 30 days after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol treatment were included in this analysis.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt inhibitor MK2206: Given PO

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3+ Adverse Event
13
  61.9%
Grade 4+ Adverse Event
0
   0.0%
4.Secondary Outcome
Title Overall Survival
Hide Description Estimated using the method of Kaplan-Meier.
Time Frame From registration to death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that started protocol therapy were included in this analysis.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt inhibitor MK2206: Given PO

Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
10.0
(5.9 to 20.0)
5.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first. Estimated using the method of Kaplan-Meier.
Time Frame From registration to the first of either death due to any cause or progression, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who began protocol treatment were included in this analysis.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt inhibitor MK2206: Given PO

Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
3.5
(0.9 to 7.3)
6.Secondary Outcome
Title Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression)
Hide Description Evaluated using RECIST version 1.1. A Complete Response (CR) requires disappearance of all target lesions and each target lymph node must have reduction in short axis to <1.0 cm. A Partial Response (PR) requires at least a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. Progressive Disease (PD) is defined as either a new lesion of a 20% increase in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes. Stable Disease (SD) is defined as not having a PD, CR, or PR.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who began protocol treatment were included in this analysis.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt inhibitor MK2206: Given PO

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Stable Disease
11
  52.4%
Partial Response (PR)
1
   4.8%
Cmplete Response (CR)
0
   0.0%
Progressive Disease
9
  42.9%
7.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented.
Time Frame The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not conducted due to having too few patients with evaluable for this endpoint.
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description:

Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt inhibitor MK2206: Given PO

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description Akt inhibitor MK2206: 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   10/21 (47.62%)    
Ear and labyrinth disorders   
Vertigo  1  1/21 (4.76%)  1
Eye disorders   
Conjunctivitis  1  1/21 (4.76%)  1
Gastrointestinal disorders   
Constipation  1  2/21 (9.52%)  2
Dry mouth  1  1/21 (4.76%)  1
Dysphagia  1  2/21 (9.52%)  2
Gastritis  1  1/21 (4.76%)  1
Stomach pain  1  1/21 (4.76%)  1
Vomiting  1  1/21 (4.76%)  1
General disorders   
Fatigue  1  1/21 (4.76%)  1
Fever  1  3/21 (14.29%)  3
Non-cardiac chest pain  1  1/21 (4.76%)  1
Infections and infestations   
Skin infection  1  2/21 (9.52%)  3
Investigations   
Alanine aminotransferase increased  1  1/21 (4.76%)  1
Alkaline phosphatase increased  1  1/21 (4.76%)  1
Aspartate aminotransferase increased  1  1/21 (4.76%)  1
Blood bilirubin increased  1  1/21 (4.76%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  2/21 (9.52%)  4
Musculoskeletal and connective tissue disorders   
Flank pain  1  1/21 (4.76%)  1
Nervous system disorders   
Dizziness  1  1/21 (4.76%)  3
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/21 (4.76%)  1
Hiccups  1  1/21 (4.76%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/21 (4.76%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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   19/21 (90.48%)    
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other, specify  1  1/21 (4.76%)  2
Tinnitus  1  1/21 (4.76%)  1
Endocrine disorders   
Hypothyroidism  1  1/21 (4.76%)  2
Eye disorders   
Conjunctivitis  1  4/21 (19.05%)  5
Dry eye  1  1/21 (4.76%)  3
Eye disorders - Other, specify  1  2/21 (9.52%)  6
Gastrointestinal disorders   
Cheilitis  1  1/21 (4.76%)  1
Diarrhea  1  4/21 (19.05%)  6
Dry mouth  1  1/21 (4.76%)  2
Dysphagia  1  1/21 (4.76%)  2
Gastrointestinal disorders - Other, specify  1  1/21 (4.76%)  3
Mucositis oral  1  3/21 (14.29%)  10
Nausea  1  1/21 (4.76%)  2
Vomiting  1  4/21 (19.05%)  4
General disorders   
Chills  1  1/21 (4.76%)  1
Fatigue  1  9/21 (42.86%)  34
Fever  1  4/21 (19.05%)  5
Flu like symptoms  1  1/21 (4.76%)  5
Infusion site extravasation  1  1/21 (4.76%)  1
Infections and infestations   
Infections and infestations - Other, specify  1  1/21 (4.76%)  2
Lip infection  1  1/21 (4.76%)  3
Papulopustular rash  1  1/21 (4.76%)  6
Skin infection  1  1/21 (4.76%)  2
Upper respiratory infection  1  4/21 (19.05%)  5
Investigations   
Alanine aminotransferase increased  1  2/21 (9.52%)  2
Creatinine increased  1  3/21 (14.29%)  9
Electrocardiogram QT corrected interval prolonged  1  1/21 (4.76%)  1
Lymphocyte count decreased  1  1/21 (4.76%)  7
Weight loss  1  4/21 (19.05%)  15
Metabolism and nutrition disorders   
Anorexia  1  4/21 (19.05%)  10
Dehydration  1  2/21 (9.52%)  2
Hyperglycemia  1  1/21 (4.76%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/21 (4.76%)  2
Bone pain  1  1/21 (4.76%)  3
Chest wall pain  1  1/21 (4.76%)  1
Myalgia  1  2/21 (9.52%)  3
Nervous system disorders   
Paresthesia  1  1/21 (4.76%)  1
Psychiatric disorders   
Insomnia  1  2/21 (9.52%)  6
Renal and urinary disorders   
Urinary urgency  1  1/21 (4.76%)  4
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/21 (19.05%)  10
Dyspnea  1  1/21 (4.76%)  1
Laryngeal inflammation  1  1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/21 (4.76%)  1
Sore throat  1  1/21 (4.76%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  5/21 (23.81%)  25
Periorbital edema  1  1/21 (4.76%)  1
Pruritus  1  2/21 (9.52%)  8
Rash maculo-papular  1  12/21 (57.14%)  33
Vascular disorders   
Flushing  1  1/21 (4.76%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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: Brigette Buig-Yue Ma, MBBS, FRACP
Organization: Mayo Clinic
EMail: brigette@clo.cuhk.edu.hk
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01349933     History of Changes
Other Study ID Numbers: NCI-2011-02581
NCI-2011-02581 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000696863
MC1079 ( Other Identifier: Mayo Clinic )
8761 ( Other Identifier: CTEP )
P30CA015083 ( U.S. NIH Grant/Contract )
N01CM00099 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2011
First Posted: May 9, 2011
Results First Submitted: December 23, 2014
Results First Posted: January 8, 2015
Last Update Posted: December 5, 2017