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ZD6474, Vandetanib · 2 trials · 5 indications
Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Vandetanib 300 mg as a once daily oral dose, from Day 1 |
| B | EXPERIMENTAL | Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy) |
| C | PLACEBO_COMPARATOR | Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy). |
| Name | Type | Description |
|---|---|---|
| ZD6474, Vandetanib | DRUG | 300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Gemcitabine | DRUG | administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Placebo matching ZD6474 | DRUG | Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Placebo to Match ZD6474, Vandetanib | DRUG | 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
Inclusion Criteria: * Histologically or cytologically-confirmed advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma) * Patients must have measurable or evaluable but non-measura...
ZD6474 is an investigational small molecule being studied for the treatment of several cancers, including non-small cell lung cancer, prostate cancer, and advanced colorectal carcinoma. It has been evaluated in clinical trials for these oncology indications, though it remains in clinical development and is not approved.
ZD6474 is a small molecule that targets vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR) pathways. By inhibiting these receptors, it aims to block tumor angiogenesis and cancer cell growth, which is relevant to its study in solid tumors like non-small cell lung cancer.
ZD6474 is being developed by Sanofi, a global pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi has sponsored clinical trials of ZD6474 in oncology indications, including non-small cell lung cancer and prostate cancer.
ZD6474 is in Phase 1 of clinical development, though completed trials have been conducted at Phase 2. It is an investigational drug, meaning it has not received FDA approval and is still being studied for safety and efficacy in cancer patients.
ZD6474 has been studied in several completed clinical trials, including NCT00059722, which compared ZD6474 with ZD1839 in non-small cell lung cancer, and NCT00252746, a Phase IIa dose-finding study in non-small cell lung carcinoma. Other trials include NCT00071188 and NCT00659438.
Yes, ZD6474 is also known as Zactima, as referenced in a clinical trial title for patients with castration-refractory metastatic prostate cancer. This alternative name is used in some research contexts, so readers searching for Zactima will find information about ZD6474.