Trial Outcomes & Findings for Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma (NCT NCT01604772)
NCT ID: NCT01604772
Last Updated: 2019-05-01
Results Overview
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.
COMPLETED
PHASE2
16 participants
Up to 32 weeks
2019-05-01
Participant Flow
Participant milestones
| Measure |
Treatment (Akt Inhibitor MK2206)
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 Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma
Baseline characteristics by cohort
| Measure |
Treatment (Akt Inhibitor MK2206)
n=16 Participants
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
|
|---|---|
|
Age, Continuous
|
63.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 32 weeksPopulation: Two patients were deemed ineligible for this endpoint due to eligibility criteria not being met. Therefore, this endpoint is reported using 14 eligible patients.
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.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=14 Participants
|
|---|---|
|
Confirmed Response Rate (Complete Response + Partial Response) According to RECIST Version 1.1
|
0 percentage of patients
Interval 0.0 to 23.2
|
SECONDARY outcome
Timeframe: Time of study entry to progression or death, up to 3 years after registrationPopulation: Two patients were deemed ineligible and were not included in this endpoint.
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.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=14 Participants
|
|---|---|
|
Median Progression Free Survival
|
9.7 months
Interval 3.8 to 11.8
|
SECONDARY outcome
Timeframe: Time of study entry to death due to any cause, assessed up to 3 years from registrationPopulation: Two patients were not eligible for this endpoint.
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.
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=14 Participants
|
|---|---|
|
Overall Survival
|
18 months
Interval 11.8 to 29.9
|
SECONDARY outcome
Timeframe: Time to first treatment to up to 30 days after completion of treatmentPopulation: All patients that started protocol treatment were included in this analysis.
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).
Outcome measures
| Measure |
Treatment (Akt Inhibitor MK2206)
n=16 Participants
|
|---|---|
|
Incidence of Toxicities of Akt Inhibitor MK-2206
Grade 3 Adverse Event
|
10 Participants
|
|
Incidence of Toxicities of Akt Inhibitor MK-2206
Grade 4 Adverse Event
|
2 Participants
|
Adverse Events
Treatment (Akt Inhibitor MK2206)
Serious adverse events
| Measure |
Treatment (Akt Inhibitor MK2206)
n=16 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Akt Inhibitor MK2206)
n=16 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.8%
3/16 • Number of events 12
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
37.5%
6/16 • Number of events 14
|
|
Cardiac disorders
Sinus bradycardia
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Cataract
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Dry eye
|
6.2%
1/16 • Number of events 3
|
|
Eye disorders
Eye disorders - Other, specify
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Cheilitis
|
6.2%
1/16 • Number of events 10
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
4/16 • Number of events 10
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
18.8%
3/16 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • Number of events 6
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Edema limbs
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Fatigue
|
81.2%
13/16 • Number of events 38
|
|
General disorders
Pain
|
12.5%
2/16 • Number of events 3
|
|
Infections and infestations
Bronchial infection
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
2/16 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
2/16 • Number of events 6
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
2/16 • Number of events 11
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 3
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
12.5%
2/16 • Number of events 2
|
|
Investigations
Investigations - Other, specify
|
6.2%
1/16 • Number of events 4
|
|
Investigations
Lymphocyte count decreased
|
43.8%
7/16 • Number of events 12
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Platelet count decreased
|
43.8%
7/16 • Number of events 29
|
|
Investigations
Weight loss
|
31.2%
5/16 • Number of events 22
|
|
Investigations
White blood cell decreased
|
6.2%
1/16 • Number of events 10
|
|
Metabolism and nutrition disorders
Anorexia
|
37.5%
6/16 • Number of events 15
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
87.5%
14/16 • Number of events 51
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
2/16 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
2/16 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.8%
3/16 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
4/16 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
2/16 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
12.5%
2/16 • Number of events 8
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 10
|
|
Nervous system disorders
Memory impairment
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 10
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
1/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
3/16 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
4/16 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
6/16 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.2%
1/16 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
81.2%
13/16 • Number of events 58
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
12.5%
2/16 • Number of events 13
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60