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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
The purpose of this study is to test a new drug for neuroendocrine tumors. We think that this new drug may help control your tumor.
MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific target on cancer cells. This target helps the cancer cells grow and divide. By attaching to the target, it may stop the cancer cells from further growth and dividing. This study will help find out if MK-0646 is a helpful drug when taken in patients with neuroendocrine tumor.
This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, MK-0646 has on metastatic neuroendocrine tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK-0646 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0646 | Drug | MK-0646 (20 mg/mL) in sterilized solution for IV infusion (12.7 mL to deliver 12.0 mL) will be used for a dose of 10 mg/kg IV weekly administered over 60 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard Saltz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan-Kettering Cancer Center @ Suffolk |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Metastatic Neuroendocrine Tumors | Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | Rockville Centre | New York | 11570 | United States |
| Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York | 10591 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Metastatic Neuroendocrine Tumors | Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone. | Posted | Number | participants | 2 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Metastatic Neuroendocrine Tumors | Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET) | 5 | 25 | 23 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glucose, low (hypoglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Nausea | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Neck | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
| |
| Syncope (fainting) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Albumin, low (hypoalbuminemia) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Fever (in the absence of neutropenia) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diane Reidy | Memorial Sloan Kettering Cancer Center | 646-888-4185 | ReidyD@mskcc.org |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C569480 | dalotuzumab |
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