Advanced Colorectal CarcinomaPhase 1NCT00499850
Phase I FOLFOX Combination
A Phase 1 study testing ZD6474 (vandetanib), 5-Fluorouracil and Leucovorin in people with Advanced Colorectal Carcinoma, run by Genzyme, a Sanofi Company at 4 sites in Australia.
Trial summary
A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Carcinoma
- What is being tested?
- ZD6474 (vandetanib), 5-Fluorouracil and Leucovorin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 18 participants
- Where
- 4 sitesAustralia
- Study dates
- Aug 2005to Apr 2008
- 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 adenocarcinoma (Stage IV)
- WHO performance status 0-1
- one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques
Who cannot join
- Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
- last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
- prior unanticipated severe reaction to oxaliplatin
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Research Site
East Melbourne
Research Site
Footscray
Research Site
Heidelberg
Research Site
Parkville
About this study
Official title: A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.
- Conditions
- Advanced Colorectal Carcinoma
- Being tested
- ZD6474 (vandetanib), 5-Fluorouracil, Leucovorin, Oxaliplatin
- Keywords
- ZD6474, FOLFOX, colorectal, adenocarcinoma
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD6474 (vandetanib)Drug
Also called ZACTIMA™
once daily oral dose
5-FluorouracilDrug
Also called 5-FU
intravenous infusion
LeucovorinDrug
intravenous infusion
OxaliplatinDrug
intravenous infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
Measured: Assessed at each visit
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 startAug 2005
- Primary completionJun 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT00499850
- Sponsor's protocol ID
- D4200C00037
- Status last verified
- Aug 2016
- First submitted
- 10 Jul 2007
- Last updated
- 25 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT00499850
- Acronym / sponsor ID
- D4200C00037
- Conditions
- Advanced Colorectal Carcinoma
- Keywords
- ZD6474, FOLFOX, colorectal, adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Jul 2007 (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.
A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 adenocarcinoma (Stage IV)
- WHO performance status 0-1
- one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques
Key exclusion criteria (3 listed)
- Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
- last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
- prior unanticipated severe reaction to oxaliplatin
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 |
|---|---|---|
| ZD6474 (vandetanib)Also: ZACTIMA™once daily oral dose | Drug | – |
| 5-FluorouracilAlso: 5-FUintravenous infusion | Drug | – |
| Leucovorinintravenous infusion | Drug | – |
| Oxaliplatinintravenous infusion | Drug | – |
Primary outcome
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
Time frame: Assessed at each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZD6474 (vandetanib), 5-Fluorouracil and Leucovorin in people with Advanced Colorectal Carcinoma, run by Genzyme, a Sanofi Company at 4 sites 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 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 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (time frame: Assessed at each visit). 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 Aug 2016.