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Trial record 4 of 2710 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)

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ClinicalTrials.gov Identifier: NCT00610129
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neuroendocrine Tumors
Metastatic Neuroendocrine Tumors
Intervention Drug: MK-0646
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Metastatic Neuroendocrine Tumors
Hide Arm/Group Description Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
Period Title: Overall Study
Started 28
Completed 25
Not Completed 3
Reason Not Completed
Not treated since patients ineligible             3
Arm/Group Title Patients With Metastatic Neuroendocrine Tumors
Hide Arm/Group Description Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  60.7%
>=65 years
11
  39.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
12
  42.9%
Male
16
  57.1%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Metastatic Neuroendocrine Tumors
Hide Arm/Group Description:
Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Progression of Disease (POD) 13
Stable Disease (SD) 12
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Metastatic Neuroendocrine Tumors
Hide Arm/Group Description Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
All-Cause Mortality
Patients With Metastatic Neuroendocrine Tumors
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Metastatic Neuroendocrine Tumors
Affected / at Risk (%) # Events
Total   5/25 (20.00%)    
Gastrointestinal disorders   
Vomiting  1  1/25 (4.00%)  1
General disorders   
Nausea  1  2/25 (8.00%)  2
Pain - Abdomen NOS  1  1/25 (4.00%)  1
Pain - Neck  1  1/25 (4.00%)  1
Syncope (fainting)  1  1/25 (4.00%)  1
Metabolism and nutrition disorders   
Glucose, low (hypoglycemia)  1  1/25 (4.00%)  1
Renal and urinary disorders   
Renal failure  1  1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders   
Thrombosis/thrombus/embolism  1  1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients With Metastatic Neuroendocrine Tumors
Affected / at Risk (%) # Events
Total   23/25 (92.00%)    
Blood and lymphatic system disorders   
ALT, SGPT  1  6/25 (24.00%)  6
AST, SGOT  1  2/25 (8.00%)  2
Albumin, low (hypoalbuminemia)  1  3/25 (12.00%)  3
Hemoglobin  1  3/25 (12.00%)  3
Lymphopenia  1  2/25 (8.00%)  2
Gastrointestinal disorders   
Diarrhea  1  3/25 (12.00%)  3
Vomiting  1  2/25 (8.00%)  2
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  9/25 (36.00%)  9
Fever (in the absence of neutropenia)  1  2/25 (8.00%)  2
Pain - Abdomen NOS  1  4/25 (16.00%)  4
Metabolism and nutrition disorders   
Alkaline phosphatase  1  2/25 (8.00%)  2
Glucose, high (hyperglycemia)  1  14/25 (56.00%)  14
Phosphate, low (hypophosphatemia)  1  3/25 (12.00%)  3
Renal and urinary disorders   
Bilirubin (hyperbilirubinemia)  1  3/25 (12.00%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  2/25 (8.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Diane Reidy
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4185
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00610129     History of Changes
Other Study ID Numbers: 07-162
First Submitted: January 24, 2008
First Posted: February 7, 2008
Results First Submitted: October 19, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015