Trial Outcomes & Findings for Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT NCT01349933)
NCT ID: NCT01349933
Last Updated: 2017-12-05
Results Overview
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.
COMPLETED
PHASE2
21 participants
6 months
2017-12-05
Participant Flow
Participant milestones
| Measure |
Treatment (Akt Inhibitor MK2206)
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 Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Akt Inhibitor MK2206)
n=21 Participants
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
|
|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=21 Participants
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
|
|---|---|
|
Proportion of Patients Alive and Progression-free
Alive and Progression Free
|
9 participants
|
|
Proportion of Patients Alive and Progression-free
Dead or Progression
|
12 participants
|
PRIMARY outcome
Timeframe: 6 monthsEvaluated 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.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=21 Participants
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
|
|---|---|
|
Confirmed Response Rate Defined to be a CR or PR Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart
Complete Response
|
0 percentage of participants
|
|
Confirmed Response Rate Defined to be a CR or PR Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart
Partial Response
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of study treatmentPopulation: All patients that began protocol treatment were included in this analysis.
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.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=21 Participants
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
|
|---|---|
|
Adverse Events Associated With the Agent Graded Based on CTCAE Version 4.0
Grade 3+ Adverse Event
|
13 Participants
|
|
Adverse Events Associated With the Agent Graded Based on CTCAE Version 4.0
Grade 4+ Adverse Event
|
0 Participants
|
SECONDARY outcome
Timeframe: From registration to death due to any cause, assessed up to 3 yearsPopulation: All patients that started protocol therapy were included in this analysis.
Estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=21 Participants
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 Survival
|
10.0 months
Interval 5.9 to 20.0
|
SECONDARY outcome
Timeframe: From registration to the first of either death due to any cause or progression, assessed up to 3 yearsPopulation: All patients who began protocol treatment were included in this analysis.
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.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=21 Participants
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
|
|---|---|
|
Progression-free Survival
|
3.5 months
Interval 0.9 to 7.3
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All patients who began protocol treatment were included in this analysis.
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.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=21 Participants
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
|
|---|---|
|
Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression)
Stable Disease
|
11 Participants
|
|
Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression)
Partial Response (PR)
|
1 Participants
|
|
Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression)
Cmplete Response (CR)
|
0 Participants
|
|
Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression)
Progressive Disease
|
9 Participants
|
SECONDARY outcome
Timeframe: 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 yearsPopulation: Analysis not conducted due to having too few patients with evaluable for this endpoint.
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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Akt Inhibitor MK2206)
Serious adverse events
| Measure |
Treatment (Akt Inhibitor MK2206)
n=21 participants at risk
Akt inhibitor MK2206: Given PO
|
|---|---|
|
Gastrointestinal disorders
Stomach pain
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Fever
|
14.3%
3/21 • Number of events 3
|
|
General disorders
Non-cardiac chest pain
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Skin infection
|
9.5%
2/21 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
2/21 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
1/21 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
4.8%
1/21 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Akt Inhibitor MK2206)
n=21 participants at risk
Akt inhibitor MK2206: Given PO
|
|---|---|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
4.8%
1/21 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
1/21 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
4.8%
1/21 • Number of events 2
|
|
Eye disorders
Conjunctivitis
|
19.0%
4/21 • Number of events 5
|
|
Eye disorders
Dry eye
|
4.8%
1/21 • Number of events 3
|
|
Eye disorders
Eye disorders - Other, specify
|
9.5%
2/21 • Number of events 6
|
|
Gastrointestinal disorders
Cheilitis
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
4/21 • Number of events 6
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
1/21 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
1/21 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.8%
1/21 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
3/21 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
4/21 • Number of events 4
|
|
General disorders
Chills
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Fatigue
|
42.9%
9/21 • Number of events 34
|
|
General disorders
Fever
|
19.0%
4/21 • Number of events 5
|
|
General disorders
Flu like symptoms
|
4.8%
1/21 • Number of events 5
|
|
General disorders
Infusion site extravasation
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.8%
1/21 • Number of events 2
|
|
Infections and infestations
Lip infection
|
4.8%
1/21 • Number of events 3
|
|
Infections and infestations
Papulopustular rash
|
4.8%
1/21 • Number of events 6
|
|
Infections and infestations
Skin infection
|
4.8%
1/21 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
19.0%
4/21 • Number of events 5
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • Number of events 2
|
|
Investigations
Creatinine increased
|
14.3%
3/21 • Number of events 9
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
4.8%
1/21 • Number of events 7
|
|
Investigations
Weight loss
|
19.0%
4/21 • Number of events 15
|
|
Metabolism and nutrition disorders
Anorexia
|
19.0%
4/21 • Number of events 10
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
1/21 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
2/21 • Number of events 3
|
|
Nervous system disorders
Paresthesia
|
4.8%
1/21 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
9.5%
2/21 • Number of events 6
|
|
Renal and urinary disorders
Urinary urgency
|
4.8%
1/21 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
4/21 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.8%
5/21 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.5%
2/21 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
57.1%
12/21 • Number of events 33
|
|
Vascular disorders
Flushing
|
4.8%
1/21 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60