ColorectalPhase 2NCT00500292
A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer
A Phase 2 study testing Vandetanib and FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid in people with Colorectal and Cancer, run by Genzyme, a Sanofi Company at 15 sites in 6 countries.
Trial summary
The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal, Cancer
- What is being tested?
- Vandetanib and FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Mar 2007to Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Progression on or following treatment for metastatic colorectal cancer
- Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
- Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12 weeks
Who cannot join
- Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
- Previous adjuvant therapy with irinotecan within 12 months of randomisation
- More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Slovakia4 sites
Research Site
Bratislava
Research Site
Poprad
Research Site
Trnava
Research Site
Žilina
Hungary3 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Szeged
Spain3 sites
Research Site
Hospitalet deLlobregat
Research Site
Oviedo
Research Site
Santander
About this study
Official title: A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Irinotecan and Fluoropyrimidine Regimen
The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.
- Conditions
- Colorectal, Cancer
- Being tested
- Vandetanib, FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
- Keywords
- colorectal, cancer, zactima
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VandetanibDrug
Also called AZ6474, ZACTIMA™, SAR390530
once daily oral tablet two dose strengths
FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acidDrug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | FOLFOX + Placebo vandetanib Receives: Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid |
| 2 | Experimental | FOLFOX + low dose vandetanib Receives: Drug: Vandetanib; Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid |
| 3 | Experimental | FOLFOX + high dose vandetanib Receives: Drug: Vandetanib; Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With an Objective Disease Progression Event
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Measured: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ColorectalStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500292
- Sponsor's protocol ID
- D4200C00047
- Other IDs
- 2006-005022-23, LPS15025
- Status last verified
- Jan 2018
- First submitted
- 3 Jul 2007
- Last updated
- 25 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Irinotecan and Fluoropyrimidine Regimen
- ClinicalTrials.gov ID
- NCT00500292
- Acronym / sponsor ID
- D4200C00047
- Conditions
- Colorectal, Cancer
- Keywords
- colorectal, cancer, zactima
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Posted 24 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acidFOLFOX + Placebo vandetanib |
| 2 | Experimental | Drug: Vandetanib, Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acidFOLFOX + low dose vandetanib |
| 3 | Experimental | Drug: Vandetanib, Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acidFOLFOX + high dose vandetanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Progression on or following treatment for metastatic colorectal cancer
- Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
- Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12 weeks
Key exclusion criteria (3 listed)
- Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
- Previous adjuvant therapy with irinotecan within 12 months of randomisation
- More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
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 |
|---|---|---|
| VandetanibAlso: AZ6474, ZACTIMA™, SAR390530once daily oral tablet two dose strengths | Drug | 2, 3 |
| FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acidintravenous infusion | Drug | 1, 2, 3 |
Primary outcome
Number of Patients With an Objective Disease Progression Event
Time frame: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- CSR-D4200C00047.pdfLink provided by the sponsor.
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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.
Clinical Sciences & Operations study director
Sanofi
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vandetanib and FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid in people with Colorectal and Cancer, run by Genzyme, a Sanofi Company at 15 sites in 6 countries.
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 3 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: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Slovakia, Hungary, Spain, France, Taiwan and 1 more country. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With an Objective Disease Progression Event (time frame: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)). 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 25 Jan 2018.