MetastaticPhase 1NCT00507091
Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
A Phase 1 study testing ZD6474 (vandetanib) 100mg, Irinotecan and 5-Fluorouracil in people with Metastatic and Colorectal, run by Genzyme, a Sanofi Company at 3 sites in 2 countries.
Trial summary
A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic, Colorectal, Adenocarcinoma
- What is being tested?
- ZD6474 (vandetanib) 100mg, Irinotecan and 5-Fluorouracil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2005to Jun 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
- Confirmed metastatic colorectal adenocarcinoma
- Not amenable to surgery or radiation therapy
- Eligible for first or second line chemotherapy
Who cannot join
- Brain metastases or spinal compression
- Last prior chemotherapy discontinued within 4 weeks before start
- Last dose radiotherapy within 4 weeks of start
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.
A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.
- Conditions
- Metastatic, Colorectal, Adenocarcinoma
- Being tested
- ZD6474 (vandetanib) 100mg, Irinotecan, 5-Fluorouracil, Leucovorin, ZD6474 (vandetanib) 300mg
- Keywords
- ZD6474, Irinotecan, 5-Fluorouracil, Leucovorin, colorectal
- Medical subject headings
- Neoplasm Metastasis, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD6474 (vandetanib) 100mgDrug
Also called ZACTIMA™
once daily oral tablet
IrinotecanDrug
Also called Camptosar®
intravenous infusion
5-FluorouracilDrug
Also called 5-FU
intravenous infusion
LeucovorinDrug
intravenous infusion
ZD6474 (vandetanib) 300mgDrug
Also called ZACTIMA™
once daily oral tablet
| Study group | Role | What they receive |
|---|---|---|
| ZD6474 (vandetanib) 100mg | Experimental | Not described Receives: Drug: ZD6474 (vandetanib) 100mg; Drug: Irinotecan; Drug: 5-Fluorouracil; Drug: Leucovorin |
| ZD6474 (vandetanib) 300mg | Experimental | Not described Receives: Drug: Irinotecan; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: ZD6474 (vandetanib) 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations
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 posted25 Jul 2007 (estimated)
- Study startAug 2005
- Primary completionMay 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MetastaticStudies 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
- 24 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
- NCT00507091
- Sponsor's protocol ID
- D4200C00038
- Status last verified
- Aug 2016
- First submitted
- 10 Jul 2007
- Last updated
- 25 Aug 2016
- Results posted
- No
Publications
Saunders MP, Wilson R, Peeters M, Smith R, Godwood A, Oliver S, Van Cutsem E. Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. Cancer Chemother Pharmacol. 2009 Sep;64(4):665-72. doi: 10.1007/s00280-008-0914-4. Epub 2009 Jan 29.
PubMed 19184020
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 Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT00507091
- Acronym / sponsor ID
- D4200C00038
- Conditions
- Metastatic, Colorectal, Adenocarcinoma
- Keywords
- ZD6474, Irinotecan, 5-Fluorouracil, Leucovorin, colorectal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 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 asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZD6474 (vandetanib) 100mg | Experimental | Drug: ZD6474 (vandetanib) 100mg, Drug: Irinotecan, Drug: 5-Fluorouracil, Drug: Leucovorin |
| ZD6474 (vandetanib) 300mg | Experimental | Drug: Irinotecan, Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: ZD6474 (vandetanib) 300mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed metastatic colorectal adenocarcinoma
- Not amenable to surgery or radiation therapy
- Eligible for first or second line chemotherapy
Key exclusion criteria (3 listed)
- Brain metastases or spinal compression
- Last prior chemotherapy discontinued within 4 weeks before start
- Last dose radiotherapy within 4 weeks of start
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) 100mgAlso: ZACTIMA™once daily oral tablet | Drug | ZD6474 (vandetanib) 100mg |
| IrinotecanAlso: Camptosar®intravenous infusion | Drug | ZD6474 (vandetanib) 100mg, ZD6474 (vandetanib) 300mg |
| 5-FluorouracilAlso: 5-FUintravenous infusion | Drug | ZD6474 (vandetanib) 100mg, ZD6474 (vandetanib) 300mg |
| Leucovorinintravenous infusion | Drug | ZD6474 (vandetanib) 100mg, ZD6474 (vandetanib) 300mg |
| ZD6474 (vandetanib) 300mgAlso: ZACTIMA™once daily oral tablet | Drug | ZD6474 (vandetanib) 300mg |
Primary outcome
Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations
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.
- Background: PubMed 19184020Saunders MP, Wilson R, Peeters M, Smith R, Godwood A, Oliver S, Van Cutsem E. Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. Cancer Chemother Pharmacol. 2009 Sep;64(4):665-72. doi: 10.1007/s00280-008-0914-4. Epub 2009 Jan 29.
- Related InfoLink provided by the sponsor.
- CSR-D4200C00038.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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZD6474 (vandetanib) 100mg, Irinotecan and 5-Fluorouracil in people with Metastatic and Colorectal, run by Genzyme, a Sanofi Company at 3 sites in 2 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 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 3 sites in United Kingdom, Belgium. 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?
Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations (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?
On the ClinicalTrials.gov record for NCT00507091, which also lists 1 linked publication.
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.