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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00551096 | Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors | PHASE1 | COMPLETED | 23 | — | — | Oct 1, 2007 | May 1, 2013 | Dec 25, 2013 | 1 | United States |
To evaluate the safety profile and determine the MTD dose of ZACTIMA in combination with Gemcitabine and Capecitabine in patients with advanced malignancies. Toxicity will be graded per Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0 and adverse event reporting for this study will be performed via Adverse Event Expedited Reporting System (AdEERS). All patients who receive any amount of the study drug will be evaluable for toxicity.
| Arm | Type | Description |
|---|---|---|
| Gemcitabine, capecitabine and ZD6474 | EXPERIMENTAL | Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2. Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off . ZD6474 administered orally at 300 mg/day once daily. One cycle will consist of 28 days. |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2. |
| Capecitabine | DRUG | Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off. |
| ZD6474 | DRUG | Administered orally at 300 mg/day once daily. One cycle will consist of 28 days |
Inclusion Criteria: * Age 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (measure of your ability to perform everyday tasks) * Life expectancy of at least three months Blood samples and other testing may apply for further testing of eligibility. Exclusion ...