CS-1008 Used With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Treatment With Oxaliplatin

Sponsor
Daiichi Sankyo
Study ID
NCT00969033
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • CS-1008 — DRUG
    CS-1008
  • irinotecan — DRUG
    irinotecan

Study Details

The purpose of this study is to determine the effect of CS-1008 in combination with irinotecan compared to irinotecan alone on Progression-Free Survival (PFS) in subjects with metastatic or advanced colorectal cancer (CRC) who have failed oxaliplatin-based first-line treatment.

Key Dates

Start date
Jul 31, 2009
Status verified
Jan 2012
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

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

Arms

  • Experimental: CS-1008 with irinotecan
    CS-1008 and irinotecan
  • Active Comparator: irintoecan
    irinotecan alone

Primary Outcome Measure

Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone. [ Time Frame: 1 year ]

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