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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01434069 | Phase I Trial of Combination of FOLFIRI and SOM 230 | PHASE1 | COMPLETED | 16 | — | — | Sep 1, 2011 | Dec 1, 2015 | Dec 24, 2015 | 1 | United States |
To determine the maximum tolerated dose (using a standard 3+3 design), of SOM 230 and FOLFIRI.
| Arm | Type | Description |
|---|---|---|
| Combination Therapy: FOLFIRI and SOM 230 | EXPERIMENTAL | Treatment will be administered on an outpatient basis. FOLFIRI is administered by IV infusion every 2 weeks. The dose should be based on the patient's actual baseline body weight; the dose will be recalculated if there is a weight change of \> 10% from baseline. SOM 230 will be administered as an intramuscular dose determined by the dosing schema, every 28 days. |
| Name | Type | Description |
|---|---|---|
| SOM230C LAR | DRUG | Participants will be given one LAR dose injected into the muscle of the buttocks by a study nurse about once every 28 days until unacceptable toxicity or progression of the disease. |
| FOLFIRI Infusion | DRUG | Standard therapy of FOLFIRI |
Inclusion Criteria: * Histologically proven metastatic/unresectable gastrointestinal malignancies (colon, small bowel, pancreas, gastric and esophageal cancer, etc.) not amenable to curative surgical therapy, for whom FOLFIRI can be considered a standard treatment * Have had at least 1 prior treatm...