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CompletedNCT00499850Updated Aug 25, 2016

Phase I FOLFOX Combination

A Phase 1 interventional study of ZD6474 (vandetanib) and 5-Fluorouracil in Advanced Colorectal Carcinoma, sponsored by Genzyme, a Sanofi Company. Completed at 4 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-25.

Sponsored by Genzyme, a Sanofi Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Colorectal Carcinoma

Keywords

  • ZD6474
  • FOLFOX
  • colorectal
  • adenocarcinoma
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 18 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV)
  2. WHO performance status 0-1
  3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques

Exclusion criteria

Exclusion Criteria:

  1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
  2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
  3. prior unanticipated severe reaction to oxaliplatin
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Interventions

  • DrugZD6474 (vandetanib)

    once daily oral dose

    Also known as: ZACTIMA™

  • Drug5-Fluorouracil

    intravenous infusion

    Also known as: 5-FU

  • DrugLeucovorin

    intravenous infusion

  • DrugOxaliplatin

    intravenous infusion

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin

    Time frame: Assessed at each visit

07

Study locations

4 sites
  • Research Site
    East Melbourne, Australia
  • Research Site
    Footscray, Australia
  • Research Site
    Heidelberg, Australia
  • Research Site
    Parkville, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00499850
Lead sponsor
Genzyme, a Sanofi Company
Responsible party
Sponsor
First posted
Jul 12, 2007
Start date
Aug 2005
Primary completion
Jun 2006
Completion
Apr 2008
Last update
Aug 25, 2016

Study contacts

Clinical Sciences & Operations
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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