Trial · NCT00686036
Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
NCT00686036, Phase 2, Terminated, Genzyme, a Sanofi Company; results first posted 2011-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy. Trials, record NCT00686036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00686036
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
- NCT number
- NCT00686036
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Prostate Cancer
- Interventions
- vandetanib, Placebo
- First posted
- 2008-05-29
- Last updated
- 2016-12-21
- Results first posted
- 2011-05-24
- Limitations and caveats
It was planned that approx 100 patients would be recruited over a period of approx 2 years, due to slow recruitment the study was terminated early. No statistical analyses was done and no conclusion can be drawn about the outcomes in this study.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) | 52 weeks | |
| Secondary | Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) | 78 weeks during off-treatment phase of ADT | |
| Secondary | Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL) | From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL | |
| Secondary | Serum Testosterone Levels | Change from baseline at each visit post-randomization until until week 78 |
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 | Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) | 52 weeks | Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed. | ||
| SECONDARY | Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) | 78 weeks during off-treatment phase of ADT | Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed. | ||
| SECONDARY | Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL) | From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL | Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed. | ||
| SECONDARY | Serum Testosterone Levels | Change from baseline at each visit post-randomization until until week 78 | Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib | 9 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Vandetanib | 0 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Vandetanib | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events158
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 | Diarrhoea | Gastrointestinal disorders | Vandetanib | 7 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 8 | |
| other | Nausea | Gastrointestinal disorders | Vandetanib | 3 | 9 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 8 | |
| other | Fatigue | General disorders | Vandetanib | 2 | 9 | |
| other | Fatigue | General disorders | Placebo | 3 | 8 | |
| other | Oedema peripheral | Gastrointestinal disorders | Vandetanib | 2 | 9 | |
| other | Oedema peripheral | Gastrointestinal disorders | Placebo | 3 | 8 | |
| other | Nasopharyngitis | Infections and infestations | Vandetanib | 2 | 9 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 8 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse 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 | 9 | 9 |
| Total, other adverse events | Placebo | 8 | 8 |
| Total, serious adverse events | Vandetanib | 1 | 9 |
| Total, serious adverse events | Placebo | 1 | 8 |
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 |
|---|
| Vandetanib 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/NCT00686036
GET https://conductscience.org/api/trials/v1/NCT00686036/events?page=2