Trial · NCT00537095

Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer

NCT00537095, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2011-07-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer. Trials, record NCT00537095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00537095

On this page

Trial

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

Title: Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer
NCT number: NCT00537095
Status: Completed
Phases: Phase 2
Enrollment: 164 participants, actual
Lead sponsor: Genzyme, a Sanofi Company
Conditions: Thyroid Neoplasms
Interventions: Vandetanib, Placebo
First posted: 2007-09-28
Last updated: 2024-04-19
Other registries' IDs: eudract:2007-001890-27
Results first posted: 2011-07-08

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Time to Tumor Progression	Time from date of randomization to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment	modified RECIST V1.0 was used.
Secondary	Disease Control Rate at 6 Months	6 months after randomization	number of participants that achieved disease control 6 months after randomization. Best objective response of complete response + partial response + stable disease \> 24 weeks according to RECIST criteria
Secondary	Objective Response Rate	46.7 months	Best objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria
Secondary	Time to Death	time from randomization to date of death	Interim analysis time to date of randomization to date of death (data not mature at the time of this analysis, so number of deaths displayed instead.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Tumor Progression	Time from date of randomization to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment		days	MEDIAN
SECONDARY	Disease Control Rate at 6 Months	6 months after randomization		participants	NUMBER
SECONDARY	Objective Response Rate	46.7 months		participants	NUMBER
SECONDARY	Time to Death	time from randomization to date of death	For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. For the safety part, 73 patients received at least one dose of ZD6474 and 72 placebo	participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Time to Tumor Progression	ZD6474	334	95% Confidence Interval 232 to 421	days
Time to Tumor Progression	PLACEBO	176	95% Confidence Interval 119 to 267	days
Disease Control Rate at 6 Months	ZD6474	41		participants
Disease Control Rate at 6 Months	PLACEBO	31		participants
Objective Response Rate	ZD6474	6		participants
Objective Response Rate	PLACEBO	4		participants
Time to Death	ZD6474	19		participants
Time to Death	PLACEBO	21		participants

Source ClinicalTrials.gov

Participant flow16

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

Period	Milestone	Group	Participants
Randomized Treatment Period (433 Days)	STARTED	ZD6474/ ZD6474	72
Randomized Treatment Period (433 Days)	STARTED	PLACEBO/ ZD6474	73
Randomized Treatment Period (433 Days)	Safety Population	ZD6474/ ZD6474	73
Randomized Treatment Period (433 Days)	Safety Population	PLACEBO/ ZD6474	72
Randomized Treatment Period (433 Days)	COMPLETED	ZD6474/ ZD6474	0
Randomized Treatment Period (433 Days)	COMPLETED	PLACEBO/ ZD6474	0
Randomized Treatment Period (433 Days)	NOT COMPLETED	ZD6474/ ZD6474	72
Randomized Treatment Period (433 Days)	NOT COMPLETED	PLACEBO/ ZD6474	73
Open-label Period (590 Days)	STARTED	ZD6474/ ZD6474	28
Open-label Period (590 Days)	STARTED	PLACEBO/ ZD6474	59

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events528

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	Events
other	Anaemia	Blood and lymphatic system disorders	Randomized Treatment Period: Vandetanib (ZD6474)	0	73	0
other	Anaemia	Blood and lymphatic system disorders	Randomized Treatment Period: Placebo	4	72	5
other	Anaemia	Blood and lymphatic system disorders	Open-Label Treatment Period: Vandetanib/Vandetinib (ZD6474)	1	29	1
other	Anaemia	Blood and lymphatic system disorders	Open-Label Treatment Period: Placebo/Vandetinib (ZD6474)	2	58	2
other	Leukopenia	Blood and lymphatic system disorders	Randomized Treatment Period: Vandetanib (ZD6474)	4	73	4
other	Leukopenia	Blood and lymphatic system disorders	Randomized Treatment Period: Placebo	0	72	0
other	Leukopenia	Blood and lymphatic system disorders	Open-Label Treatment Period: Vandetanib/Vandetinib (ZD6474)	0	29	0
other	Leukopenia	Blood and lymphatic system disorders	Open-Label Treatment Period: Placebo/Vandetinib (ZD6474)	1	58	1
other	Neutropenia	Blood and lymphatic system disorders	Randomized Treatment Period: Vandetanib (ZD6474)	4	73	5
other	Neutropenia	Blood and lymphatic system disorders	Randomized Treatment Period: Placebo	0	72	0

1 to 10 of 528Source ClinicalTrials.gov

See all 528 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Randomized Treatment Period: Vandetanib (ZD6474)
Total, all-cause mortality	Randomized Treatment Period: Placebo
Total, all-cause mortality	Open-Label Treatment Period: Vandetanib/Vandetinib (ZD6474)
Total, all-cause mortality	Open-Label Treatment Period: Placebo/Vandetinib (ZD6474)
Total, other adverse events	Randomized Treatment Period: Vandetanib (ZD6474)	72	73
Total, other adverse events	Randomized Treatment Period: Placebo	65	72
Total, other adverse events	Open-Label Treatment Period: Vandetanib/Vandetinib (ZD6474)	17	29
Total, other adverse events	Open-Label Treatment Period: Placebo/Vandetinib (ZD6474)	54	58
Total, serious adverse events	Randomized Treatment Period: Vandetanib (ZD6474)	20	73
Total, serious adverse events	Randomized Treatment Period: Placebo	12	72

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22898678	DERIVED

Source PubMed

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 comparisons3

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

Comparison	Source
ZD6474 vs PLACEBO: Objective Response Rate	Trial comparisons
ZD6474 vs PLACEBO: Time to Death	Trial comparisons
ZD6474 vs PLACEBO: Disease Control Rate at 6 Months	Trial comparisons

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/NCT00537095

GET https://conductscience.org/api/trials/v1/NCT00537095/events?page=2

API reference For AI assistants