Pfizer initiated a Phase III trial to evaluate the safety and efficacy of sunitinib malate, in combination with a standard chemotherapy regimen, in patients with metastatic colorectal cancer (mCRC). Also, new data from a Phase I study showed that sunitinib malate is active and generally well-tolerated in combination with a standard chemotherapy regimen, FOLFIRI, in previously untreated patients with mCRC. These data support further evaluation of sunitinib malate in mCRC in a Phase III program.

The Phase III study is currently enrolling in Europe, Canada, Asia and South America and will include more than 700 patients to evaluate the safety and efficacy of sunitinib malate combined with FOLFIRI, a standard chemotherapy regimen used in mCRC comprised of fluorouracil (5-FU), folinic acid (leucovorin), and irinotecan, compared with FOLFIRI plus placebo, in the first-line treatment of patients with mCRC.