Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced Colorectal Cancer

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
GlaxoSmithKline
Study ID
NCT00536809
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms, Colorectal

Eligibility Criteria

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

Interventions

  • lapatinib — DRUG
    onced daily Days 1-21
  • oxaliplatin — DRUG
    Day one of each cycle
  • capecitabine — DRUG
    given BID days 1-14

Study Details

The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.

Key Dates

Start date
Sep 26, 2007
Status verified
Nov 2017
Primary completion
Oct 31, 2008
Completion
Oct 31, 2008

Study Design

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

Arms

  • Experimental: Phase I
    Dose escalation of lapatinib along with capecitabine and oxaliplatin until the maximum tolerated dose is reached.
  • Experimental: Phase II
    Treatinng subjects at the maximum tolerated dose of lapatinib, capecitabine, and oxaliplatin

Primary Outcome Measure

Overall Response in Phase II [ Time Frame: Baseline to response (up to 135 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteMadisonWisconsin53792-

Find similar trials in Madison, WI

By research site
GSK Investigational Site· Madison, WI

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