Trial · NCT00554229
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
NCT00554229, Phase 3, Completed, AstraZeneca; results first posted 2012-05-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases. Trials, record NCT00554229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00554229
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 Hormone Resistant Prostate Cancer With Bone Metastases
- NCT number
- NCT00554229
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 896 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Prostate Cancer
- Interventions
- ZD4054, Placebo
- First posted
- 2007-11-06
- Last updated
- 2016-02-08
- Other registries' IDs
- eudract:2007-003227-20
- Results first posted
- 2012-05-31
Source ClinicalTrials.gov
Registered outcomes10
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 32 months | Median time (in months) from randomisation until death using the Kaplan-Meier method |
| Secondary | Progression Free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months | Median time (in months) from randomisation until clinical progression of disease, 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, using the Kaplan-Meier method |
| Secondary | Time to Use of Opiates | From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months | Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration ≥1 week using the Kaplan-Meier method |
| Secondary | Incidence of Skeletal Related Events | From date of randomization until occurrence of a skeletal related event, assessed up to 31 months | Median time (in months) from randomisation until occurrence of a skeletal related event, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression, using the Kaplan-Meier method. |
| Secondary | Bone Metastases Formation | Patients were assessed every 12 weeks | Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method |
| Secondary | Health Related Quality of Life | Patients were assessed at every visit | Median time (in months) from randomisation until deterioration of Health related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits. |
| Secondary | Time to Prostate-specific Antigen (PSA) Progression | Patients were assessed every 12 weeks | Median time (in months) from randomisation to first PSA value \>50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method. |
| Secondary | Time to Pain Progression | Patients were assessed every 12 weeks | Median time (in months) from randomisation to first assessment of an increased pain event, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery. |
| Secondary | Time to Initiation of Chemotherapy | Patients were assessed every 12 weeks | Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method |
| Secondary | Pharmacokinetic Characteristics of ZD4054 | PK samples were performed at randomisation, Week 4, Week 8 and Week 12 |
Source ClinicalTrials.gov
Outcomes10
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 32 months | months | MEDIAN | |
| SECONDARY | Progression Free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months | Months | MEDIAN | |
| SECONDARY | Time to Use of Opiates | From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months | Months | MEDIAN | |
| SECONDARY | Incidence of Skeletal Related Events | From date of randomization until occurrence of a skeletal related event, assessed up to 31 months | Months | MEDIAN | |
| SECONDARY | Bone Metastases Formation | Patients were assessed every 12 weeks | Months | MEDIAN | |
| SECONDARY | Health Related Quality of Life | Patients were assessed at every visit | Months | MEDIAN | |
| SECONDARY | Time to Prostate-specific Antigen (PSA) Progression | Patients were assessed every 12 weeks | Months | MEDIAN | |
| SECONDARY | Time to Pain Progression | Patients were assessed every 12 weeks | Months | MEDIAN | |
| SECONDARY | Time to Initiation of Chemotherapy | Patients were assessed every 12 weeks | Months | MEDIAN | |
| SECONDARY | Pharmacokinetic Characteristics of ZD4054 | PK samples were performed at randomisation, Week 4, Week 8 and Week 12 | Plasma concentration versus time | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | ZD4054 | 24.5 | Full Range 0.5 to 31.2 | months | |
| Overall Survival | Placebo | 22.5 | Full Range 0.5 to 29.8 | months | |
| Progression Free Survival | ZD4054 | 6.2 | Inter-Quartile Range 2.8 to 13.8 | Months | |
| Progression Free Survival | Placebo | 6.5 | Inter-Quartile Range 2.8 to 13.2 | Months | |
| Time to Use of Opiates | ZD4054 | 16.7 | Inter-Quartile Range 7.3 to 27.0 | Months | |
| Time to Use of Opiates | Placebo | 14.8 | Inter-Quartile Range 7.9 to 25.8 | Months | |
| Incidence of Skeletal Related Events | ZD4054 | 18.4 | Inter-Quartile Range 9.6 to 30.6 | Months | |
| Incidence of Skeletal Related Events | Placebo | 17.1 | Inter-Quartile Range 9.3 to 25.8 | Months | |
| Bone Metastases Formation | ZD4054 | 15.1 | Inter-Quartile Range 7.2 to 25.5 | Months | |
| Bone Metastases Formation | Placebo | 11.9 | Inter-Quartile Range 7.0 to 22.5 | Months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ZD4054 | 299 | |
| Overall Study | STARTED | Placebo | 295 | |
| Overall Study | Patients Who Received Treatment | ZD4054 | 298 | |
| Overall Study | Patients Who Received Treatment | Placebo | 295 | |
| Overall Study | COMPLETED | ZD4054 | 73 | |
| Overall Study | COMPLETED | Placebo | 70 | |
| Overall Study | NOT COMPLETED | ZD4054 | 226 | |
| Overall Study | NOT COMPLETED | Placebo | 225 |
Source ClinicalTrials.gov
Adverse events404
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 | ZD4054 | 46 | 298 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 33 | 295 | |
| other | Neutropenia | Blood and lymphatic system disorders | ZD4054 | 11 | 298 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 16 | 295 | |
| other | Nausea | Gastrointestinal disorders | ZD4054 | 62 | 298 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 44 | 295 | |
| other | Constipation | Gastrointestinal disorders | ZD4054 | 61 | 298 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 51 | 295 | |
| other | Diarrhoea | Gastrointestinal disorders | ZD4054 | 28 | 298 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 46 | 295 |
1 to 10 of 404Source ClinicalTrials.gov
See all 404 adverse eventsAdverse 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 | 257 | 298 |
| Total, other adverse events | Placebo | 221 | 295 |
| Total, serious adverse events | ZD4054 | 98 | 298 |
| Total, serious adverse events | Placebo | 105 | 295 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ZD4054 vs Placebo: serious adverse events |
Source 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.
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/NCT00554229
GET https://conductscience.org/api/trials/v1/NCT00554229/events?page=2