Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01271166
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Colorectal Cancer

Eligibility Criteria

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

Interventions

Study Details

This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to the toxicities observed. Once the MTD has been determined the dose level below will be re-opened and extra patients, to a total of 15, will be enrolled.

Key Dates

First listed
Jan 6, 2011
Start date
Oct 31, 2007
Status verified
Jan 2011
Primary completion
Aug 31, 2009

Study Design

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

Arms

  • Experimental: Glivec®, modified FOLFOX, Avastin®

Primary Outcome Measure

Tumour response as assessed by CT scan and RESIST [ Time Frame: 6 months ]

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