EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer

Sponsor
Merck KGaA, Darmstadt, Germany
Study ID
NCT01008475
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • EMD 525797 250 mg — DRUG
    EMD 525797 will be administered at a target dose of 250 mg as a 1-hour intravenous infusion for every 2 week until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
  • EMD 525797 500 mg — DRUG
    Safety part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent . Randomized part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
  • EMD 525797 750 mg — DRUG
    EMD 525797 will be administered at a target dose of 750 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
  • EMD 525797 1000 mg — DRUG
    Safety part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent . Randomized part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
  • Cetuximab — DRUG
    Safety part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly until DLT. Randomized part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
  • Irinotecan — DRUG
    Safety part: Irinotecan will be administered at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent . Randomized part: Irinotecan will be administered at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.

Study Details

The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.

Key Dates

Start date
Oct 31, 2009
Status verified
Feb 2016
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

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

Arms

  • Experimental: Safety part: EMD 525797 250 mg + Standard of Care (SoC)
    EMD 525797 250 mg in combination with cetuximab and irinotecan
  • Experimental: Safety part: EMD 525797 500 mg + SoC
    EMD 525797 500 mg in combination with cetuximab and irinotecan
  • Experimental: Safety part: EMD 525797 750 mg + SoC
    EMD 525797 750 mg in combination with cetuximab and irinotecan
  • Experimental: Safety part: EMD 525797 1000 mg + SoC
    EMD 525797 1000 mg in combination with cetuximab and irinotecan
  • Experimental: Randomized part: EMD 525797 500 mg + SoC
    EMD 525797 500 mg in combination with cetuximab and irinotecan
  • Experimental: Randomized Part: EMD 525797 1000 mg + SoC
    EMD 525797 1000 mg (or dose as defined by safety monitoring committee (SMC)\] in combination with cetuximab and irinotecan.
  • Other: Randomized Part: SoC
    Cetuximab and irinotecan

Primary Outcome Measure

Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) [ Time Frame: Time from the first dose of study drug up to 2 weeks ]

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