Trial · NCT00498797

E3-Hormone Refractory Prostrate Cancer Taxotere Combination

NCT00498797, Phase 2, Completed, Sanofi; results first posted 2011-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. E3-Hormone Refractory Prostrate Cancer Taxotere Combination. Trials, record NCT00498797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00498797

On this page

Trial

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

Title: E3-Hormone Refractory Prostrate Cancer Taxotere Combination
NCT number: NCT00498797
Status: Completed
Phases: Phase 2
Enrollment: 86 participants, actual
Lead sponsor: Sanofi
Conditions: Prostate Cancer, Metastatic, Hormone Refractory
Interventions: Zactima (vandetanib), Docetaxel, Prednisolone
First posted: 2007-07-10
Last updated: 2016-10-07
Other registries' IDs: eudract:2005-003593-16
Results first posted: 2011-05-24

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Prostate Specific Antigen (PSA) Response	PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline	Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response
Secondary	Number of Patients With an Objective Disease Progression Event	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 (21 July 2007 or up to 7 days in advance of DCO)	Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Prostate Specific Antigen (PSA) Response	PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline		Participants	NUMBER
SECONDARY	Number of Patients With an Objective Disease Progression Event	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 (21 July 2007 or up to 7 days in advance of DCO)		Participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Prostate Specific Antigen (PSA) Response	Vandetanib	17	Participants
Prostate Specific Antigen (PSA) Response	Placebo	29	Participants
Number of Patients With an Objective Disease Progression Event	Vandetanib	28	Participants
Number of Patients With an Objective Disease Progression Event	Placebo	26	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vandetanib	43
Overall Study	STARTED	Placebo	43
Overall Study	COMPLETED	Vandetanib	5
Overall Study	COMPLETED	Placebo	14
Overall Study	NOT COMPLETED	Vandetanib	38
Overall Study	NOT COMPLETED	Placebo	29

Source ClinicalTrials.gov

Adverse events174

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	ANAEMIA	Blood and lymphatic system disorders	Vandetanib	1	43
other	ANAEMIA	Blood and lymphatic system disorders	Placebo	5	43
other	NEUTROPENIA	Blood and lymphatic system disorders	Vandetanib	3	43
other	NEUTROPENIA	Blood and lymphatic system disorders	Placebo	4	43
other	LEUKOPENIA	Blood and lymphatic system disorders	Vandetanib	1	43
other	LEUKOPENIA	Blood and lymphatic system disorders	Placebo	3	43
other	PALPITATIONS	Cardiac disorders	Vandetanib	3	43
other	PALPITATIONS	Cardiac disorders	Placebo	0	43
other	VERTIGO	Ear and labyrinth disorders	Vandetanib	3	43
other	VERTIGO	Ear and labyrinth disorders	Placebo	1	43

1 to 10 of 174Source ClinicalTrials.gov

See all 174 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vandetanib
Total, all-cause mortality	Placebo
Total, other adverse events	Vandetanib	38	43
Total, other adverse events	Placebo	39	43
Total, serious adverse events	Vandetanib	23	43
Total, serious adverse events	Placebo	15	43

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 comparisons3

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

Comparison	Source
Vandetanib vs Placebo: Number of Patients With an Objective Disease Progression Event	Trial comparisons
Vandetanib vs Placebo: Prostate Specific Antigen (PSA) Response	Trial comparisons
Vandetanib vs Placebo: serious adverse events	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/NCT00498797

GET https://conductscience.org/api/trials/v1/NCT00498797/events?page=2

API reference For AI assistants