NCT00499850

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

July 10, 2007

Last Update Submit

August 24, 2016

Conditions

Advanced Colorectal Carcinoma

Keywords

ZD6474FOLFOXcolorectaladenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

    Assessed at each visit

Interventions

ZD6474 (vandetanib)DRUG

once daily oral dose

Also known as: ZACTIMA™
5-FluorouracilDRUG

intravenous infusion

Also known as: 5-FU
LeucovorinDRUG

intravenous infusion

OxaliplatinDRUG

intravenous infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

East Melbourne, Australia

Location

Research Site

Footscray, Australia

Location

Research Site

Heidelberg, Australia

Location

Research Site

Parkville, Australia

Location

MeSH Terms

Conditions

Adenocarcinoma

Interventions

vandetanibFluorouracilLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 12, 2007

Study Start

August 1, 2005

Primary Completion

June 1, 2006

Study Completion

April 1, 2008

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

AU(4)