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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01253161 | Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs) | PHASE2 | COMPLETED | 29 | — | — | Feb 1, 2011 | Mar 2, 2023 | Mar 6, 2023 | 2 | United States |
PFS: Defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) guidelines, or death due to any cause. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
| Arm | Type | Description |
|---|---|---|
| Pasireotide LAR Treatment | EXPERIMENTAL | The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg. |
| Name | Type | Description |
|---|---|---|
| Pasireotide Long Acting Release (LAR) | DRUG | Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent. |
Inclusion Criteria: * Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors * Tumors must be considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded fr...