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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01271166




Trial ID
NCT01271166
Ethics application status
Date submitted
4/01/2011
Date registered
5/01/2011
Date last updated
5/01/2011

Titles & IDs
Public title
Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
Scientific title
Secondary ID [1] 0 0
CSTI571BAU14
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Experimental: Glivec®, modified FOLFOX, Avastin® -


Treatment: Drugs: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tumour response as assessed by CT scan and RESIST
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
- Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer

- ECOG 0 or 1

- Measurable disease
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novarts Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01271166
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries