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

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Colorectal CancerNeoplasms, Colorectal
Interventions
DRUG

CS7017

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.

DRUG

irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)

"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)"

Trial Locations (18)

41

Oncosalud SAC, Lima

20007

John Marshall, Washington D.C.

20817

Victor Priego, Bethesda

30341

Georgia Cancer Specialists, Atlanta

44718

Gabrail Cancer Center, Canton

90211

Beverly Hills Cancer Center, Beverly Hills

92835

St. Jude Heritage Medical Group, Fullerton

2540364

Instituto Oncologico Clinica Renaca, Viña del Mar

8320000

Fundacion Arturo Lopez Perez, Santiago

8380455

Instituto Nacional del Cancer, Santiago

B1900BAJ

Instituto FIDES Oncologia y Especialidades Medicas, Buenos Aires

T4000GTB

CAIPO Centro para la Atencion Integral del Paciente Oncologico, San Miguel de Tucumán

90610-000

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul - PUC-RS, Porto Alegre

20231-050

Instituto Nacional de Cancer INCA, Rio de Janeiro

01209-000

ICAVC, São Paulo

Unknown

Hospital Nacional Alberto Sabogai Sologuren, Callao

Hospital Nacional Dos de Mayo, Lima

01

Hospital Nacional Dos de Mayo, Lima

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY