Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

Sponsor
Shanghai Zhangjiang Biotechnology Limited Company
Study ID
NCT01550055
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CMAB009 plus Irinotecan — DRUG
    Combined with irinotecan 180 mg/m2 every 2 weeks, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression
  • Irinotecan-only and sequential-CMAB009 — DRUG
    First, irinotecan 180 mg/m2 every 2 weeks till PD occured, discontinue it; then, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression.

Study Details

The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients

Key Dates

Start date
May 31, 2009
Status verified
Apr 2019
Primary completion
Dec 23, 2012
Completion
Jul 23, 2015

Study Design

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

Arms

  • Experimental: CMAB009 plus Irinotecan
  • Active Comparator: Irinotecan-only and sequential-CMAB009

Primary Outcome Measure

Overall response rate [ Time Frame: Time to progression, assessed up to two years ]

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