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Trial record 98 of 2732 for:    tumor | Neuroendocrine Tumors

Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)

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ClinicalTrials.gov Identifier: NCT01169649
Recruitment Status : Completed
First Posted : July 26, 2010
Results First Posted : February 18, 2016
Last Update Posted : February 18, 2016
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 PANCREAS
Neuroendocrine
Intervention Drug: MK-2206
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK-2206 in Patients With Metastatic Neuroendocrine Tumors
Hide Arm/Group Description This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
Period Title: Overall Study
Started 11
Completed 8
Not Completed 3
Reason Not Completed
Patient Not Treated             3
Arm/Group Title MK-2206 in Patients With Metastatic Neuroendocrine Tumors
Hide Arm/Group Description This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  81.8%
>=65 years
2
  18.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
1.Primary Outcome
Title Overall Response.
Hide Description 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.
Time Frame every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MK-2206 in Patients With Metastatic Neuroendocrine Tumors
Hide Arm/Group Description:
This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
Stable Disease 6
Progression of Disease 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK-2206 in Patients With Metastatic Neuroendocrine Tumors
Hide Arm/Group Description This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
All-Cause Mortality
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
Affected / at Risk (%) # Events
Total   4/8 (50.00%)    
Metabolism and nutrition disorders   
Hypoglycemia  1  2/8 (25.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms  1  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MK-2206 in Patients With Metastatic Neuroendocrine Tumors
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Alanine aminotransferase increased  1  2/8 (25.00%)  2
Aspartate aminotransferase increased  1  2/8 (25.00%)  2
Lymphocyte count decreased  1  3/8 (37.50%)  3
White blood cell decreased  1  1/8 (12.50%)  1
Gastrointestinal disorders   
Diarrhea  1  2/8 (25.00%)  2
General disorders   
Anorexia  1  1/8 (12.50%)  1
Edema limbs  1  1/8 (12.50%)  1
Fatigue  1  3/8 (37.50%)  3
Metabolism and nutrition disorders   
Alkaline phosphatase increased  1  3/8 (37.50%)  3
Blood bilirubin increased  1  2/8 (25.00%)  2
Hyperglycemia  1  5/8 (62.50%)  5
Hypoalbuminemia  1  2/8 (25.00%)  2
Hypoglycemia  1  2/8 (25.00%)  2
Hypophosphatemia  1  2/8 (25.00%)  2
Lipase increased  1  1/8 (12.50%)  1
Serum amylase increased  1  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  1/8 (12.50%)  1
Pruritus  1  2/8 (25.00%)  2
Rash maculo-papular  1  4/8 (50.00%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Diane Reidy-Lagunes
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4185
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01169649     History of Changes
Other Study ID Numbers: 10-067
First Submitted: July 21, 2010
First Posted: July 26, 2010
Results First Submitted: April 8, 2015
Results First Posted: February 18, 2016
Last Update Posted: February 18, 2016