Study of Pazopanib, Irinotecan and Cetuximab in Combination to Treat 2nd Line Metastatic Colorectal Cancer

Sponsor
GlaxoSmithKline
Study ID
NCT00540943
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms, Colorectal

Eligibility Criteria

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

Interventions

  • Pazopanib — DRUG
    Pazopanib is a potent, multi-targeted tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit.
  • Cetuximab — DRUG
    Cetuximab will be supplied as a single-use 50 milliliter vial containing 100 micrograms of cetuximab as a sterile, preservative-free, injectable liquid at a concentration of 2 milligram per milliliter in phosphate. buffered saline
  • Irinotecan — DRUG
    Irinotecan hydrochloride trihydrate is an antineoplastic agent of the topoisomerase I inhibitor class.

Study Details

Subjects will be entered into cohorts of 3 for the dose escalation phase so that the maximum tolerated dose can be determined. 18 additional patients will be recruited once the maximum tolerated dose (MTD) is determined for disease assessment.

Key Dates

Start date
Jul 13, 2007
Status verified
Nov 2017
Primary completion
May 3, 2010
Completion
May 3, 2010

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    irinotecan and cetuximab in combination with pazopanib.

Primary Outcome Measure

The safety and tolerability of the maximum tolerated dose defined as a dose regimen where no more than 1 of 6 subjects experiences a dose limiting toxicity. [ Time Frame: End of 2009 ]

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