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

Novartis logo

Novartis

Status and phase

Terminated
Phase 1

Conditions

Advanced Colorectal Cancer

Treatments

Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01271166
CSTI571BAU14

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer
  • ECOG 0 or 1
  • Measurable disease

Exclusion criteria

  • Prior first line therapy for advanced disease
  • Significant bulk of metastatic disease or rapid progression
  • If prior adjuvant therapy, relapse within 6 months of a 5-FU based regimen or 12 months of an oxaliplatin based regimen

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Glivec®, modified FOLFOX, Avastin®
Experimental group
Treatment:
Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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