Trial · NCT00626548

A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer

NCT00626548, Phase 3, Terminated, AstraZeneca; results first posted 2012-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer. Trials, record NCT00626548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00626548

On this page

Trial

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

Title: A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
NCT number: NCT00626548
Status: Terminated
Phases: Phase 3
Enrollment: 2,577 participants, actual
Lead sponsor: AstraZeneca
Conditions: Prostate Cancer
Interventions: ZD4054, Palcebo
First posted: 2008-02-29
Last updated: 2012-09-03
Results first posted: 2012-06-01

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Overall Survival	From date of randomization until date of death, assessed up to 33 months	Number of participants who have died at early analysis data cut off (DCO)
Primary	Progression Free Survival	Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks	Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline
Secondary	Health Related Quality of Life	Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Secondary	Time to Prostate-specific Antigen (PSA) Progression	Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Secondary	Time to Symptomatic Progression	Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	From date of randomization until date of death, assessed up to 33 months	The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)	Participants	NUMBER
PRIMARY	Progression Free Survival	Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks	The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)	Participants	NUMBER
SECONDARY	Health Related Quality of Life	Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
SECONDARY	Time to Prostate-specific Antigen (PSA) Progression	Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
SECONDARY	Time to Symptomatic Progression	Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

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
Overall Survival	ZD4054	40	Participants
Overall Survival	Placebo	39	Participants
Progression Free Survival	ZD4054	131	Participants
Progression Free Survival	Placebo	162	Participants

Source ClinicalTrials.gov

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ZD4054	705
Overall Study	STARTED	Placebo	716
Overall Study	Patients Received Treatment	ZD4054	703
Overall Study	Patients Received Treatment	Placebo	712
Overall Study	COMPLETED	ZD4054	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	ZD4054	705
Overall Study	NOT COMPLETED	Placebo	716

Source ClinicalTrials.gov

Adverse events478

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	ZD4054	46	703
other	Anaemia	Blood and lymphatic system disorders	Placebo	23	712
other	Constipation	Gastrointestinal disorders	ZD4054	64	703
other	Constipation	Gastrointestinal disorders	Placebo	76	712
other	Diarrhoea	Gastrointestinal disorders	ZD4054	46	703
other	Diarrhoea	Gastrointestinal disorders	Placebo	63	712
other	Nausea	Gastrointestinal disorders	ZD4054	59	703
other	Nausea	Gastrointestinal disorders	Placebo	61	712
other	Oedema Peripheral	General disorders	ZD4054	268	703
other	Oedema Peripheral	General disorders	Placebo	88	712

1 to 10 of 478Source ClinicalTrials.gov

See all 478 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ZD4054
Total, all-cause mortality	Placebo
Total, other adverse events	ZD4054	531	703
Total, other adverse events	Placebo	392	712
Total, serious adverse events	ZD4054	148	703
Total, serious adverse events	Placebo	138	712

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
ZD4054 vs Placebo: Progression Free Survival	Trial comparisons
ZD4054 vs Placebo: Overall Survival	Trial comparisons
ZD4054 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/NCT00626548

GET https://conductscience.org/api/trials/v1/NCT00626548/events?page=2

API reference For AI assistants