Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZD6474 · 1 trial · 3 indications
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 ...
ZD6474 is an investigational small molecule being studied for the treatment of malignant solid tumours, including biliary cancer and pancreatic cancer. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
ZD6474 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical trials for oncology indications.
ZD6474 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to evaluate its safety and efficacy in patients with malignant solid tumours.
ZD6474 has been studied in one completed Phase 1 clinical trial with the identifier NCT00551096, titled 'Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors'. This trial enrolled 23 participants in the United States and included patients with malignant solid tumours, biliary cancer, and pancreatic cancer.
ZD6474 is also known as vandetanib, a small molecule drug being developed by AstraZeneca. It is currently in Phase 1 clinical trials for the treatment of malignant solid tumours, including biliary and pancreatic cancers.