Advanced Colorectal CancerPhase 1NCT01271166
Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
A Phase 1 study testing Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab in people with Advanced Colorectal Cancer, run by Novartis Pharmaceuticals at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2007to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer
- ECOG 0 or 1
- Measurable disease
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab
- Keywords
- Colorectal,, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and BevacizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Glivec®, modified FOLFOX, Avastin® | Experimental | Not described Receives: Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour response as assessed by CT scan and RESIST
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startOct 2007
- Primary completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271166
- Sponsor's protocol ID
- CSTI571BAU14
- Status last verified
- Jan 2011
- First submitted
- 4 Jan 2011
- Last updated
- 6 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01271166
- Acronym / sponsor ID
- CSTI571BAU14
- Conditions
- Advanced Colorectal Cancer
- Keywords
- Colorectal,, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glivec®, modified FOLFOX, Avastin® | Experimental | Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer
- ECOG 0 or 1
- Measurable disease
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab | Drug | Glivec®, modified FOLFOX, Avastin® |
Primary outcome
Tumour response as assessed by CT scan and RESIST
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab in people with Advanced Colorectal Cancer, run by Novartis Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour response as assessed by CT scan and RESIST (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2011.