Phase I Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Participants With Colorectal Cancer (MK-0646-016)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00925015
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dalotuzumab 10 mg/kg — BIOLOGICAL
    Dalotuzumab at 10 mg/kg was intravenously administered once weekly
  • Cetuximab — BIOLOGICAL
    Following pre-treatment with a histamine-receptor antagonist, Cetuximab was administered with an initial intravenous infusion of 400 mg/m\^2, followed by subsequent once weekly intravenous infusions of 250 mg/m\^2
  • Irinotecan — DRUG
    Irinotecan was administered with an intravenous infusion of 150 mg/m\^2, once every other week for 42 days
  • Dalotuzumab 15/7.5 mg/kg — BIOLOGICAL
    Dalotuzumab was intravenously administered, with the first infusion of 15 mg/kg, followed by subsequent infusions of 7.5 mg/kg

Study Details

The purposes of this study were to assess the safety, tolerability, pharmacokinetic interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.

Key Dates

Start date
Jun 17, 2009
Status verified
Jul 2018
Primary completion
Jul 28, 2010
Completion
Dec 6, 2010

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cetux/Irin - Dmab 10 mg/kg
    After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
  • Experimental: Cetux/Irin - Dmab 15/7.5 mg/kg
    After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Days 8, 22 and 36; followed in subsequent cycles by treatment with 7.5 mg/kg on Days 8, 22 and 36. Each cycle was 6 weeks long.
  • Experimental: Dmab 10 mg/kg - Cetux/Irin (DDI)
    Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For Drug-Drug Interaction (DDI). Each cycle was 6 weeks long.

Primary Outcome Measure

Number of Dose-limiting Toxicities (DLTs) [ Time Frame: Four weeks of Cycle 1 treatment (up to 28 days) ]

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