NCT00454116

Brief Summary

The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Mar 2007

Geographic Reach
6 countries

21 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
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 24, 2011

Completed
Last Updated

October 7, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

March 28, 2007

Results QC Date

April 27, 2011

Last Update Submit

August 25, 2016

Conditions

Colorectal Cancer

Keywords

Colon CancerRectal Cancer

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)

    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 (28 March 2008 +/-3 days)

Study Arms (3)

1

PLACEBO COMPARATOR

FOLFIRI + placebo vandetanib

Drug: FOLFIRI

2

EXPERIMENTAL

FOLFIRI + low dose vandetanib

Drug: VandetanibDrug: FOLFIRI

3

EXPERIMENTAL

FOLFIRI + high dose vandetanib

Drug: VandetanibDrug: FOLFIRI

Interventions

VandetanibDRUG

once daily oral tablet two doses

Also known as: ZD6474, ZACTIMA™
23
FOLFIRIDRUG

Intravenous infusion

123

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed colorectal cancer
  • Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
  • Progression on or following treatment for metastatic colorectal cancer
  • Progression within 12 months of adjuvant chemotherapy for colorectal cancer

You may not qualify if:

  • Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
  • Previous adjuvant therapy with irinotecan within 12 months of randomization
  • More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Research Site

Ann Arbor, Michigan, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

Research Site

Buenos Aires, Argentina

Location

Research Site

Ramos Mejía, Argentina

Location

Research Site

Rosario, Argentina

Location

Research Site

Santa Fe, Argentina

Location

Research Site

Vicente López, Argentina

Location

Research Site

Bergen, Norway

Location

Research Site

Oslo, Norway

Location

Research Site

Stavanger, Norway

Location

Research Site

Seoul, South Korea

Location

Research Site

A Coruña, Spain

Location

Research Site

Barcelona, Spain

Location

Research Site

Jaén, Spain

Location

Research Site

Lleida, Spain

Location

Research site

Belfast, Northern Ireland, United Kingdom

Location

Research Site

Aberdeen, United Kingdom

Location

Research Site

Leicester, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

vandetanibIFL protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

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

March 28, 2007

First Posted

March 30, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

November 1, 2009

Last Updated

October 7, 2016

Results First Posted

May 24, 2011

Record last verified: 2016-08

Locations

ES(4)AR(5)NO(3)US(4)KR(1)GB(4)