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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to test a new drug called MK-2206. This study is a phase II study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a new treatment has against a certain type of cancer.
MK-2206 is an oral medication known as a targeted therapy. By attaching to the target, we hope that MK-2206 may stop the cancer cells from further growth and dividing. This study will help find out if MK-2206 is a helpful drug when taken in patients with neuroendocrine tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| islet cell carcinomas and carcinoid tumors | Experimental | This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2206 | Drug | MK-2206 will be given orally 200 mg qw as given in the prior Ph1 clinical trial that demonstrated safety, tolerability and adequate PK/PD values at this dose. Follow-up imaging scans will be performed every 12 weeks to evaluate response. Patients must take MK-2206 orally at least 2 hours before or 2 hours after food or a meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response. | 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. | every 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Reidy-Lagunes, MD,MS | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 |
| 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 | Overall Response. | 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. | Posted | Number | participants | every 12 weeks |
|
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diane Reidy-Lagunes | Memorial Sloan Kettering Cancer Center | 646-888-4185 | reidyd@mskcc.org |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C548887 | MK 2206 |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 4 |
| 8 |
| 8 |
| 8 |
| Hypoglycemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTC-4.0 | Systematic Assessment |
|
| Alkaline phosphatase increased | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Anorexia | General disorders | CTC-4.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
|
| Blood bilirubin increased | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTC-4.0 | Systematic Assessment |
|
| Edema limbs | General disorders | CTC-4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTC-4.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Lipase increased | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTC-4.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTC-4.0 | Systematic Assessment |
|
| Serum amylase increased | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| White blood cell decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
|
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| D009380 | Neoplasms, Nerve Tissue |