NCT01271166

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

1.8 years

First QC Date

January 4, 2011

Last Update Submit

January 5, 2011

Conditions

Advanced Colorectal Cancer

Keywords

Colorectal,Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumour response as assessed by CT scan and RESIST

    6 months

Study Arms (1)

Glivec®, modified FOLFOX, Avastin®

EXPERIMENTAL
Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Interventions

Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and BevacizumabDRUG
Glivec®, modified FOLFOX, Avastin®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novarts Investigative Site

Melbourne, Australia

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Imatinib MesylateFluorouracilOxaliplatinLeucovorinBevacizumab

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesUracilPyrimidinonesCoordination ComplexesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 6, 2011

Study Start

October 1, 2007

Primary Completion

August 1, 2009

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

AU(1)