Trial · NCT00659438
Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
NCT00659438, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2012-07-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer. Trials, record NCT00659438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00659438
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
- NCT number
- NCT00659438
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 95 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Prostate Cancer
- Interventions
- ZD6474 (Vandetanib), Bicalutamide, Placebo
- First posted
- 2008-04-16
- Last updated
- 2016-12-05
- Other registries' IDs
- eudract:2007-001891-35
- Results first posted
- 2012-07-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months | 4 months | To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set). PSA progression free rate defined as the number of participants with : * After decline from baseline: a 25% increase above the nadir * No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL) |
| Secondary | Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression) | 4 months | Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to PSA progression was not evaluated. PFS was evaluated instead, whether biological or clinical progression. |
| Secondary | Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms) | 4 months | Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to onset of cancer-related symptoms was not evaluated. PFS was evaluated instead, whether biological or clinical progression. |
| Secondary | PSA Response Rate | 4 months | To investigate the effect of vandetanib on the PSA response rate. PSA response rate defined by the number of participants with a PSA decrease relative to baseline of at least 50%. A minimum decrease of 2 ng/mL in absolute value and a confirmation on at least 2 consecutive occasions (at least 4 weeks apart) were requested. |
| Secondary | Overall Survival (OS) | End of study (July 2011) | To investigate the effect of vandetanib on overall survival. Patients alive at the time of the statistical analysis were censored at the time they were last known to be alive. Due to censored data, median overall survival in the placebo group cannot be calculated. OS defined as the number of participants who were alive. |
| Secondary | Progression Rate From the Radionuclide Bone Scanning | 4 months | To describe the effect of vandetanib on progression rate from the radionuclide bone scanning in a sub-group of patients who had a bone scan within 3 to 6 months after 1st treatment dose. Number of participants with at least 2 new lesions on the radionuclide bone scan compared to baseline assessment were counted for calculation of progression rate. |
| Secondary | Number of Circulating Tumour Cells (CTC) (in Patients Included in Ile de France Centres Only) | 4 months | To investigate the effect of vandetanib on CTC. Numbering of CTCs to be performed at baseline, 1 week, 1 and 2 months after randomisation. This study was proposed only to patients followed in a study centre located in Ile de France. Correlation between the number of CTCs and PSA response was to be estimated after 1 week, 1 and 2 months of treatment |
| Secondary | Number of Circulating Endothelial Cells (CEC) of Tumour Blood Cells (in Patients Included in Ile de France Centres Only) | 4 months | To investigate the effect of vandetanib on CEC. Numbering of CECs was to be performed at baseline, 1 week, 1 month and 2 months after randomisation. Correlation between the number of CECs and PSA response was to be estimated after 1 week, 1 month and 2 months of treatment. |
| Secondary | Number of Patients With CECs, CTCs and Gene Signature Profile of CTCs | 4 months | To investigate the relationship between response to vandetanib, CTCs and CECs. To investigate gene signature profile of antiangiogenic response by gene micro-array analysis of CTCs. Gene signature profile of CTCs was aimed to be compared before and after 2 months of treatment. No blood sample has been taken for the study, and so results on CTCs, CECs of tumour vessels and gene and signature profiles of CTCs were not performed. |
Source ClinicalTrials.gov
Outcomes9
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) Progression Free Rate at 4 Months | 4 months | Participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression) | 4 months | weeks | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms) | 4 months | weeks | MEDIAN | |
| SECONDARY | PSA Response Rate | 4 months | Participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | End of study (July 2011) | participants | NUMBER | |
| SECONDARY | Progression Rate From the Radionuclide Bone Scanning | 4 months | Participants | NUMBER | |
| SECONDARY | Number of Circulating Tumour Cells (CTC) (in Patients Included in Ile de France Centres Only) | 4 months | This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed. | ||
| SECONDARY | Number of Circulating Endothelial Cells (CEC) of Tumour Blood Cells (in Patients Included in Ile de France Centres Only) | 4 months | This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed. | ||
| SECONDARY | Number of Patients With CECs, CTCs and Gene Signature Profile of CTCs | 4 months |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months | Vandetanib | 8 | Participants | ||
| Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months | Placebo | 7 | Participants | ||
| Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression) | Vandetanib | 12.2 | 95% Confidence Interval 11.8 to 12.4 | weeks | |
| Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression) | Placebo | 12.8 | 95% Confidence Interval 12.2 to 13.6 | weeks | |
| Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms) | Vandetanib | 12.2 | 95% Confidence Interval 11.8 to 12.4 | weeks | |
| Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms) | Placebo | 12.8 | 95% Confidence Interval 12.2 to 13.6 | weeks | |
| PSA Response Rate | Vandetanib | 3 | Participants | ||
| PSA Response Rate | Placebo | 5 | Participants | ||
| Overall Survival (OS) | Vandetanib | 32 | 24.2 to ? | participants | |
| Overall Survival (OS) | Placebo | 35 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib | 47 | |
| Overall Study | STARTED | Placebo | 48 | |
| Overall Study | Assessable Set : Primary Analysis | Vandetanib | 44 | |
| Overall Study | Assessable Set : Primary Analysis | Placebo | 45 | |
| Overall Study | Secondary Analysis Set | Vandetanib | 47 | |
| Overall Study | Secondary Analysis Set | Placebo | 48 | |
| Overall Study | Safety Analysis Set | Vandetanib | 48 | |
| Overall Study | Safety Analysis Set | Placebo | 47 | |
| Overall Study | COMPLETED | Vandetanib | 33 | |
| Overall Study | COMPLETED | Placebo | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events142
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 | Fatigue | General disorders | Vandetanib | 2 | 48 | |
| other | Fatigue | General disorders | Placebo | 3 | 47 | |
| other | Asthenia | General disorders | Vandetanib | 20 | 48 | |
| other | Asthenia | General disorders | Placebo | 19 | 47 | |
| other | Diarrhoea | Gastrointestinal disorders | Vandetanib | 21 | 48 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 47 | |
| other | Constipation | Gastrointestinal disorders | Vandetanib | 8 | 48 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 8 | 47 | |
| other | Nausea | Gastrointestinal disorders | Vandetanib | 9 | 48 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 47 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 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 | 47 | 48 |
| Total, other adverse events | Placebo | 47 | 47 |
| Total, serious adverse events | Vandetanib | 17 | 48 |
| Total, serious adverse events | Placebo | 4 | 47 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vandetanib vs Placebo: Overall Survival (OS) | Trial comparisons |
| Vandetanib vs Placebo: PSA Response Rate | Trial comparisons |
| Vandetanib vs Placebo: Progression Rate From the Radionuclide Bone Scanning | Trial comparisons |
| Vandetanib vs Placebo: Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months | 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.
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/NCT00659438
GET https://conductscience.org/api/trials/v1/NCT00659438/events?page=2