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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00471146 | Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer. | PHASE3 | COMPLETED | 630 | — | — | Jul 1, 2007 | Nov 1, 2010 | Jul 16, 2012 | 204 | United States, Argentina +22 |
Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AG-013736 | DRUG | oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression. |
| Gemcitabine | DRUG | intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression. |
| placebo | DRUG | placebo |
Inclusion Criteria: * Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection. * Adequate renal, hepatic and bone marrow function. * Performance status 0 or 1. Exclusion Criteria: * Prior treatment with any systemic ...