Conditions: Colorectal Cancer Neoplasms, Colorectal
Keywords: metastatic colon rectum combination chemotherapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study will be conducted at up to 18 study centers in the US, Central America, and South America. Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy will participate in the study, which will be conducted on an outpatient basis. It is anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.

Detailed description:

Arms:
arm 1: Participants who received irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). FOLFIRI was administered by intravenous (IV) injection once every 2 weeks. The FOLFIRI regimen consisted of:

* Irinotecan, 180 mg/m\^2 IV infusion over 30 to 120 minutes
* Leucovorin, 400 mg/m\^2 IV infusion to match the duration of the irinotecan infusion
* 5-FU, 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46 to 48 hours continuous infusion) arm 2: Participants who received CS7017 plus irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). Two CS-7017 tablets were administered by mouth (PO) twice a day (BID) every 12 hours. FOLFIRI was administered IV once every 2 weeks. The FOLFIRI regimen consisted of:

* Irinotecan, 180 mg/m\^2 IV infusion over 30 to 120 minutes
* Leucovorin, 400 mg/m\^2 IV infusion to match the duration of the irinotecan infusion
* 5-FU, 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46 to 48 hours continuous infusion)

Interventions: intervention 1: CS7017 intervention 2: irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)
Intervention descriptions: intervention 1: CS-7017 (0.25mg tablet) Two CS-7017 tablets will be administered by mouth (PO) BID every 12 hours. FOLFIRI will be administered IV once every 2 weeks. intervention 2: FOLFIRI will be administered IV once every 2 weeks.

The FOLFIRI regimen consists of:

* Irinotecan, 180 mg/m\^2 IV infusion over 30 to 120 minutes
* Leucovorin, 400 mg/m\^2 IV infusion to match the duration of the irinotecan infusion
* 5-FU, 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46 to 48 hours continuous infusion)

Protocol document: