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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00363051 | Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy | PHASE2 | COMPLETED | 160 | — | — | Jun 1, 2006 | Apr 1, 2012 | May 10, 2013 | 54 | United States, Argentina +9 |
Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
| Arm | Type | Description |
|---|---|---|
| Everolimus 10 mg | EXPERIMENTAL | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
| Name | Type | Description |
|---|---|---|
| Everolimus 10 mg | DRUG | Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced. |
| Octreotide Depot | DRUG | - |
Inclusion criteria for both strata: * Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET) * Confirmed low-grade or intermediate-grade neuroendocrine carcinoma * Objective disease progression by Response Evaluation Criteria in Solid tumors (RECIST) criteria whil...