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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01222936 | LBH Phase II in Small Cell Lung Cancer (SCLC) | PHASE2 | COMPLETED | 21 | — | — | May 1, 2008 | Aug 1, 2010 | Oct 18, 2010 | 8 | Germany, Italy |
Objective response rate measured according to the RECIST (Response Evaluation Criteria In Solid Tumours).
| Name | Type | Description |
|---|---|---|
| LBH581 | DRUG | 25 mg/5 ml solution packaged in 6 ml type I glass vials and given as a 30 minutes infusion at the dose of 20 mg/m2 i.v., on day 1 and 8, every 21 days. |
Inclusion Criteria: 1. Histological/cytological diagnosis of SCLC, mixed small and non small cell tumours are excluded 2. ≤ 2 prior chemotherapy lines 3. Progression after, and not during, last previous chemotherapy treatment 4. Age ≥ 18 and ≤ 75 years 5. Life expectancy of at least 3 months 6. ECO...