Trial · NCT00617669
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
NCT00617669, Phase 3, Completed, AstraZeneca; results first posted 2012-05-31
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer. Trials, record NCT00617669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00617669
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) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
- NCT number
- NCT00617669
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,494 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Prostate Cancer
- Interventions
- Docetaxel, ZD4054, Placebo
- First posted
- 2008-02-18
- Last updated
- 2012-09-10
- Results first posted
- 2012-05-31
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Patients were followed for survival up to 40 months | Median time (in months) from randomisation until death using the Kaplan-Meier method. |
| Secondary | Progression Free Survival | Patients were followed for progression up to 40 months | Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. 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 | Incidence of Skeletal Related Events | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, 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. |
| Secondary | Time to Prostate-specific Antigen (PSA) Progression | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | Median time (in months) from randomisation until 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 | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, 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 | Pain Response | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline. |
| Secondary | Health Related Quality of Life | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | 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 | PSA Response | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | PSA response defined as \>50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Patients were followed for survival up to 40 months | Full Analysis Set | Months | MEDIAN |
| SECONDARY | Progression Free Survival | Patients were followed for progression up to 40 months | Full Analysis Set | Months | MEDIAN |
| SECONDARY | Incidence of Skeletal Related Events | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | Full Analysis Set | Months | MEDIAN |
| SECONDARY | Time to Prostate-specific Antigen (PSA) Progression | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | Months | MEDIAN | |
| SECONDARY | Time to Pain Progression | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | Full Analysis Set | Months | MEDIAN |
| SECONDARY | Pain Response | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | The Pain Response Analysis Set includes patients who were either receiving opiates at baseline (randomisation) or with a baseline BPI score ≥2. | Participants | NUMBER |
| SECONDARY | Health Related Quality of Life | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | Full Analysis Set | Months | MEDIAN |
| SECONDARY | PSA Response | While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months) | Full Analysis Set | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | ZD4054 + Docetaxel | 20.0 | Inter-Quartile Range 11.6 to 32.0 | Months | |
| Overall Survival | Placebo + Docetaxel | 19.2 | Inter-Quartile Range 12.0 to 30.3 | Months | |
| Progression Free Survival | ZD4054 + Docetaxel | 7.0 | Inter-Quartile Range 3.5 to 13.1 | Months | |
| Progression Free Survival | Placebo + Docetaxel | 7.9 | Inter-Quartile Range 4.0 to 12.6 | Months | |
| Incidence of Skeletal Related Events | ZD4054 + Docetaxel | 17.4 | Inter-Quartile Range 10.0 to 25.3 | Months | |
| Incidence of Skeletal Related Events | Placebo + Docetaxel | 17.3 | Inter-Quartile Range 10.3 to 26.0 | Months | |
| Time to Prostate-specific Antigen (PSA) Progression | ZD4054 + Docetaxel | 11.9 | Inter-Quartile Range 6.2 to 19.6 | Months | |
| Time to Prostate-specific Antigen (PSA) Progression | Placebo + Docetaxel | 12.1 | Inter-Quartile Range 6.0 to 18.3 | Months | |
| Time to Pain Progression | ZD4054 + Docetaxel | 9.3 | Inter-Quartile Range 3.9 to 18.4 | Months | |
| Time to Pain Progression | Placebo + Docetaxel | 10.0 | Inter-Quartile Range 4.2 to 18.6 | Months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 + Docetaxel | 524 | |
| Overall Study | STARTED | Placebo + Docetaxel | 528 | |
| Overall Study | Patients Who Received IP | ZD4054 + Docetaxel | 522 | |
| Overall Study | Patients Who Received IP | Placebo + Docetaxel | 525 | |
| Overall Study | COMPLETED | ZD4054 + Docetaxel | 94 | |
| Overall Study | COMPLETED | Placebo + Docetaxel | 77 | |
| Overall Study | NOT COMPLETED | ZD4054 + Docetaxel | 430 | |
| Overall Study | NOT COMPLETED | Placebo + Docetaxel | 451 |
Source ClinicalTrials.gov
Adverse events614
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 + Docetaxel | 155 | 522 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Docetaxel | 116 | 525 | |
| other | Neutropenia | Blood and lymphatic system disorders | ZD4054 + Docetaxel | 114 | 522 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Docetaxel | 118 | 525 | |
| other | Leukopenia | Blood and lymphatic system disorders | ZD4054 + Docetaxel | 64 | 522 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Docetaxel | 60 | 525 | |
| other | Lacrimation Increased | Eye disorders | ZD4054 + Docetaxel | 38 | 522 | |
| other | Lacrimation Increased | Eye disorders | Placebo + Docetaxel | 36 | 525 | |
| other | Diarrhoea | Gastrointestinal disorders | ZD4054 + Docetaxel | 183 | 522 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Docetaxel | 185 | 525 |
1 to 10 of 614Source ClinicalTrials.gov
See all 614 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZD4054 + Docetaxel | ||
| Total, all-cause mortality | Placebo + Docetaxel | ||
| Total, other adverse events | ZD4054 + Docetaxel | 490 | 522 |
| Total, other adverse events | Placebo + Docetaxel | 483 | 525 |
| Total, serious adverse events | ZD4054 + Docetaxel | 214 | 522 |
| Total, serious adverse events | Placebo + Docetaxel | 203 | 525 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23569308 | 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 |
|---|---|
| ZD4054 + Docetaxel vs Placebo + Docetaxel: PSA Response | Trial comparisons |
| ZD4054 + Docetaxel vs Placebo + Docetaxel: Pain Response | Trial comparisons |
| ZD4054 + Docetaxel vs Placebo + Docetaxel: 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.
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/NCT00617669
GET https://conductscience.org/api/trials/v1/NCT00617669/events?page=2