Trial · NCT00454116

A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients

NCT00454116, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2011-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients. Trials, record NCT00454116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00454116

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients
NCT number: NCT00454116
Status: Completed
Phases: Phase 2
Enrollment: 106 participants, actual
Lead sponsor: Genzyme, a Sanofi Company
Conditions: Colorectal Cancer
Interventions: Vandetanib, FOLFIRI
First posted: 2007-03-30
Last updated: 2016-10-07
Other registries' IDs: eudract:2006-005023-42
Results first posted: 2011-05-24

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients With an Objective Disease Progression Event	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)	Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With an Objective Disease Progression Event	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)		Participants	NUMBER

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Patients With an Objective Disease Progression Event	Vandetanib 100 mg Plus FOLFIRI	20	Participants
Number of Patients With an Objective Disease Progression Event	Vandetanib 300 mg Plus FOLFIRI	24	Participants
Number of Patients With an Objective Disease Progression Event	Placebo Plus FOLFIRI	24	Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vandetanib 100 mg Plus FOLFIRI	35
Overall Study	STARTED	Vandetanib 300 mg Plus FOLFIRI	36
Overall Study	STARTED	Placebo Plus FOLFIRI	35
Overall Study	COMPLETED	Vandetanib 100 mg Plus FOLFIRI	8
Overall Study	COMPLETED	Vandetanib 300 mg Plus FOLFIRI	7
Overall Study	COMPLETED	Placebo Plus FOLFIRI	7
Overall Study	NOT COMPLETED	Vandetanib 100 mg Plus FOLFIRI	27
Overall Study	NOT COMPLETED	Vandetanib 300 mg Plus FOLFIRI	29
Overall Study	NOT COMPLETED	Placebo Plus FOLFIRI	28

Source ClinicalTrials.gov

Adverse events303

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	NEUTROPENIA	Blood and lymphatic system disorders	Vandetanib 100 mg Plus FOLFIRI	16	35
other	NEUTROPENIA	Blood and lymphatic system disorders	Vandetanib 300 mg Plus FOLFIRI	17	36
other	NEUTROPENIA	Blood and lymphatic system disorders	Placebo Plus FOLFIRI	19	35
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Vandetanib 100 mg Plus FOLFIRI	2	35
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Vandetanib 300 mg Plus FOLFIRI	6	36
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Placebo Plus FOLFIRI	3	35
other	LEUKOPENIA	Blood and lymphatic system disorders	Vandetanib 100 mg Plus FOLFIRI	2	35
other	LEUKOPENIA	Blood and lymphatic system disorders	Vandetanib 300 mg Plus FOLFIRI	2	36
other	LEUKOPENIA	Blood and lymphatic system disorders	Placebo Plus FOLFIRI	4	35
other	ANAEMIA	Blood and lymphatic system disorders	Vandetanib 100 mg Plus FOLFIRI	1	35

1 to 10 of 303Source ClinicalTrials.gov

See all 303 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vandetanib 100 mg Plus FOLFIRI
Total, all-cause mortality	Vandetanib 300 mg Plus FOLFIRI
Total, all-cause mortality	Placebo Plus FOLFIRI
Total, other adverse events	Vandetanib 100 mg Plus FOLFIRI	32	35
Total, other adverse events	Vandetanib 300 mg Plus FOLFIRI	36	36
Total, other adverse events	Placebo Plus FOLFIRI	34	35
Total, serious adverse events	Vandetanib 100 mg Plus FOLFIRI	8	35
Total, serious adverse events	Vandetanib 300 mg Plus FOLFIRI	13	36
Total, serious adverse events	Placebo Plus FOLFIRI	12	35

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00454116

GET https://conductscience.org/api/trials/v1/NCT00454116/events?page=2

API reference For AI assistants