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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00412828 | A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma | PHASE1 | COMPLETED | 117 | — | — | Jun 1, 2006 | May 1, 2011 | Feb 19, 2015 | 4 | United States |
| Name | Type | Description |
|---|---|---|
| CR011-vcMMAE | DRUG | administered as an intravenous infusion of 250 mL over 90 min |
Inclusion Criteria: * Male or female with age ≥ 18 years. * Progressive or new metastatic melanoma, stage III or IV. * Measurable disease by CT / MRI * Failure of no more than 1 line of prior cytotoxic therapy. * Adequate bone marrow, renal and hepatic function * Leukocytes ≥ 3000/mm3, ANC ≥ 1,5...