NCT00500292

Brief 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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2

Geographic Reach
6 countries

15 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

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

May 24, 2011

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

July 3, 2007

Results QC Date

April 27, 2011

Last Update Submit

January 24, 2018

Conditions

ColorectalCancer

Keywords

colorectalcancerzactima

Outcome Measures

Primary Outcomes (1)

  • 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)

    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)

Study Arms (3)

1

PLACEBO COMPARATOR

FOLFOX + Placebo vandetanib

Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid

2

EXPERIMENTAL

FOLFOX + low dose vandetanib

Drug: VandetanibDrug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid

3

EXPERIMENTAL

FOLFOX + high dose vandetanib

Drug: VandetanibDrug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid

Interventions

VandetanibDRUG

once daily oral tablet two dose strengths

Also known as: AZ6474, ZACTIMA™, SAR390530
23
FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acidDRUG

intravenous infusion

123

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Lille, France

Location

Research Site

Toulouse, France

Location

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Szeged, Hungary

Location

Research Site

Bratislava, Slovakia

Location

Research Site

Poprad, Slovakia

Location

Research Site

Trnava, Slovakia

Location

Research Site

Žilina, Slovakia

Location

Research Site

Seoul, South Korea

Location

Research Site

Hospitalet deLlobregat, Spain

Location

Research Site

Oviedo, Spain

Location

Research Site

Santander, Spain

Location

Research Site

Taipei, Taiwan

Location

Research Site

Taoyuan District, Taiwan

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

vandetanibFluorouracilLeucovorin

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi
Contact-US@sanofi.com

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2007

First Posted

July 12, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

November 1, 2016

Last Updated

January 25, 2018

Results First Posted

May 24, 2011

Record last verified: 2018-01

Locations

HU(3)FR(2)SL(4)ES(3)KR(1)TW(2)