Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Daiichi Sankyo
Study ID
NCT00967616
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CS7017 — DRUG
    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.
  • irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI) — DRUG
    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)

Study Details

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.

Key Dates

Start date
Sep 30, 2009
Status verified
Apr 2020
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FOLFIRI
    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)
  • Experimental: CS7017+FOLFIRI
    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)

Primary Outcome Measure

Percentage of Participants With Progression-Free Survival at 16 Weeks After Administration of CS-7017 Combined With Irinotecan, Leucovorin, and 5-Fluorouracil (5-FU) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer [ Time Frame: Baseline to 16 weeks postdose ]

Locations (6)

FacilityCityStateZIPSite coordinators
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
St. Jude Heritage Medical GroupFullertonCalifornia92835-
John MarshallWashington D.C.District of Columbia20007-
Georgia Cancer SpecialistsAtlantaGeorgia30341-
Victor PriegoBethesdaMaryland20817-
Gabrail Cancer CenterCantonOhio44718-

Find similar trials in Beverly Hills, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Beverly Hills Cancer Center· Beverly Hills, CASt. Jude Heritage Medical Group· Fullerton, CAJohn Marshall· Washington D.C., DCGeorgia Cancer Specialists· Atlanta, GAVictor Priego· Bethesda, MDGabrail Cancer Center· Canton, OH

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