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Vatalanib · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Oxaliplatin/5-FU/LV and PTK787/ZK 222584 |
| 2 | PLACEBO_COMPARATOR | Oxaliplatin/5-FU/LV and placebo |
| Name | Type | Description |
|---|---|---|
| Vatalanib | DRUG | - |
Inclusion criteria: * Patients with metastatic colorectal cancer coming for initial chemotherapy * Documented metastatic colorectal cancer * WHO Performance Status of 0, 1, or 2 * Measurable tumors * Adequate hematologic status, liver and kidney function * Life expectancy greater than 12 weeks * Wr...
Vatalanib is an investigational small molecule developed for colorectal neoplasms, including cancers of the colon and rectum. It has been studied in metastatic colorectal cancer in combination with oxaliplatin, 5-FU, and leucovorin chemotherapy. It is not approved for any indication and remains in clinical development.
Vatalanib is an inhibitor of PDGFRB, PDGFRA, FLT1, FLT4, KDR, and CSF1R. These targets include vascular endothelial growth factor receptors and platelet-derived growth factor receptors, which are involved in angiogenesis and tumor growth. By inhibiting these receptor kinases, vatalanib is designed to interfere with blood vessel formation in tumors.
Vatalanib is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 3 clinical program evaluating the drug in metastatic colorectal cancer. No other developer is associated with the asset in this program.
Vatalanib reached Phase 3 development for colorectal neoplasms. Both Phase 3 trials in the program are completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.
Vatalanib was evaluated in two completed Phase 3 trials: NCT00056459, which studied oxaliplatin, 5-FU, and leucovorin plus vatalanib versus chemotherapy alone in metastatic colorectal cancer, and NCT00056446, which tested the same combination in previously treated metastatic colorectal cancer. Together the trials enrolled 2,023 patients.
Yes. Both Phase 3 trials of vatalanib were randomized, double-blind, and placebo controlled. NCT00056459 enrolled 1,168 patients and NCT00056446 enrolled 855 patients, all adults aged 18 years and older with metastatic colorectal cancer. Both studies are completed.