Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01169649 | Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET) | PHASE2 | COMPLETED | 11 | — | — | Jul 1, 2010 | Feb 1, 2014 | Feb 18, 2016 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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. |
Inclusion Criteria: * Patients with histologically or cytologically confirmed moderately to well differentiated metastatic or unresectable carcinoid or islet cell tumors. * Patient has at least one measurable lesion greater than or equal to 20 mm on CT or MRI imaging. * Patients who are on therapy ...