Conditions: Colorectal Neoplasms
Keywords: Phase 1 CRC SU011248 Sunitinib FOLFOX Colorectal cancer metastatic carcinoma of the colon or rectum
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief summary:
To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: sunitinib + mFOLFOX6 intervention 2: sunitinib + mFOLFOX6
Intervention descriptions: intervention 1: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2) intervention 2: 50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)

Protocol document: