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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01601808 | Clinical Trial Comparing Gemcitabine and Vandetanib Therapy With Gemcitabine Alone in Pancreatic Carcinoma | PHASE2 | COMPLETED | 142 | — | — | Oct 10, 2011 | Sep 5, 2018 | Mar 13, 2025 | 14 | United Kingdom |
To assess whether survival times for patients receiving gemcitabine plus vandetanib are longer than for those patients receiving gemcitabine alone as first line treatment for advanced pancreatic cancer
| Arm | Type | Description |
|---|---|---|
| Gemcitabine and Placebo | PLACEBO_COMPARATOR | Standard therapeutic arm. Placebo orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles. |
| Gemcitabine and vandetanib | EXPERIMENTAL | Experimental arm. Vandetanib orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Orally once a day, continuously throughout the study |
| Caprelsa (vandetanib) | DRUG | Orally once a daily, continuously throughout the study. |
Inclusion Criteria: * Age ≥ 18 years. * Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas. * Locally advanced or metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radia...