Trial Outcomes & Findings for Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET) (NCT NCT01169649)
NCT ID: NCT01169649
Last Updated: 2016-02-18
Results Overview
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
COMPLETED
PHASE2
11 participants
every 12 weeks
2016-02-18
Participant Flow
Participant milestones
| Measure |
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
|
|---|---|
|
Overall Study
Patient Not Treated
|
3
|
Baseline Characteristics
Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)
Baseline characteristics by cohort
| Measure |
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
n=11 Participants
This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 12 weeksResponse and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
n=8 Participants
This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
|
|---|---|
|
Overall Response.
Stable Disease
|
6 participants
|
|
Overall Response.
Progression of Disease
|
2 participants
|
Adverse Events
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
Serious adverse events
| Measure |
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
n=8 participants at risk
This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
2/8 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
n=8 participants at risk
This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
|
|---|---|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
37.5%
3/8 • Number of events 3
|
|
General disorders
Anorexia
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Blood bilirubin increased
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue
|
37.5%
3/8 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
62.5%
5/8 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Lipase increased
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
37.5%
3/8 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
4/8 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum amylase increased
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
12.5%
1/8 • Number of events 1
|
Additional Information
Dr. Diane Reidy-Lagunes
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place