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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01140347 | A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib | PHASE3 | COMPLETED | 565 | — | — | Oct 1, 2010 | Mar 1, 2015 | Dec 28, 2015 | 146 | United States, Australia +25 |
OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.
| Arm | Type | Description |
|---|---|---|
| Ramucirumab DP and BSC | EXPERIMENTAL | - |
| Placebo and BSC | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | 8 mg/kg IV every 2 weeks |
| Ramucirumab DP (IMC-1121B) | BIOLOGICAL | 8 milligrams/kilogram (mg/kg) intravenous (IV) every 2 weeks |
| BSC | OTHER | Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator. |
Inclusion criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 * Child-Pugh score of \<7 (Child-Pugh Class A only) * Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC stage B not amenable to locoregional therapy or refractory to locoregional therapy * Diagnosis...