Trial Outcomes & Findings for Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET) (NCT NCT00610129)
NCT ID: NCT00610129
Last Updated: 2015-11-20
Results Overview
in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
2 years
Results posted on
2015-11-20
Participant Flow
Participant milestones
| Measure |
Patients With Metastatic Neuroendocrine Tumors
Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Patients With Metastatic Neuroendocrine Tumors
Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
|
|---|---|
|
Overall Study
Not treated since patients ineligible
|
3
|
Baseline Characteristics
Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)
Baseline characteristics by cohort
| Measure |
Patients With Metastatic Neuroendocrine Tumors
n=28 Participants
Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsin patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.
Outcome measures
| Measure |
Patients With Metastatic Neuroendocrine Tumors
n=25 Participants
Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
|
|---|---|
|
Objective Response Rate (ORR)
Progression of Disease (POD)
|
13 participants
|
|
Objective Response Rate (ORR)
Stable Disease (SD)
|
12 participants
|
Adverse Events
Patients With Metastatic Neuroendocrine Tumors
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Metastatic Neuroendocrine Tumors
n=25 participants at risk
Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
|
|---|---|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Nausea
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Pain - Abdomen NOS
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Pain - Neck
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Syncope (fainting)
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis/thrombus/embolism
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
Patients With Metastatic Neuroendocrine Tumors
n=25 participants at risk
Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
|
|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
24.0%
6/25 • Number of events 6
|
|
Blood and lymphatic system disorders
AST, SGOT
|
8.0%
2/25 • Number of events 2
|
|
Blood and lymphatic system disorders
Albumin, low (hypoalbuminemia)
|
12.0%
3/25 • Number of events 3
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
8.0%
2/25 • Number of events 2
|
|
Renal and urinary disorders
Bilirubin (hyperbilirubinemia)
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
3/25 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
36.0%
9/25 • Number of events 9
|
|
General disorders
Fever (in the absence of neutropenia)
|
8.0%
2/25 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
56.0%
14/25 • Number of events 14
|
|
Blood and lymphatic system disorders
Hemoglobin
|
12.0%
3/25 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Pain - Abdomen NOS
|
16.0%
4/25 • Number of events 4
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place