Trial · NCT00410761
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
NCT00410761, Phase 3, Completed, Genzyme, a Sanofi Company; results first posted 2012-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer. Trials, record NCT00410761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00410761
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
- NCT number
- NCT00410761
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 331 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Thyroid Cancer
- Interventions
- ZD6474 (Vandetanib)
- First posted
- 2006-12-13
- Last updated
- 2025-09-24
- Other registries' IDs
- eudract:2005-005077-29
- Results first posted
- 2012-03-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival(PFS) | RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent. | Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met. |
| Secondary | Objective Response Rate (ORR) | RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response. | The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)\>= 12 weeks, progressive disease (PD) or NE. |
| Secondary | Disease Control Rate (DCR) | RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent | Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \>= 12 weeks |
| Secondary | Duration of Response (DoR) | RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent | Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met |
| Secondary | Overall Survival (OS) | From date of randomization until death, up to approximately 105 months | OS is defined as the time from the date of randomization until death. |
| Secondary | Biochemical Response Calcitonin (CTN) | Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up | Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN. |
| Secondary | Biochemical Response Carcinoembryonic Antigen (CEA) | Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up | Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA. |
| Secondary | Time to Worsening of Pain (TWP) | During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation. | TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain. TWP results are presented. |
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 | Progression-Free Survival(PFS) | RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent. | Months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) | RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response. | Participants | NUMBER | |
| SECONDARY | Disease Control Rate (DCR) | RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent | Participants | NUMBER | |
| SECONDARY | Duration of Response (DoR) | RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent | DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From date of randomization until death, up to approximately 105 months | Months | MEDIAN | |
| SECONDARY | Biochemical Response Calcitonin (CTN) | Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up | Participants | NUMBER | |
| SECONDARY | Biochemical Response Carcinoembryonic Antigen (CEA) | Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up | Participants | NUMBER | |
| SECONDARY | Time to Worsening of Pain (TWP) | During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation. | Months | MEDIAN |
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 |
|---|---|---|---|---|---|
| Progression-Free Survival(PFS) | Vandetanib 300 mg | 30.5 | 95% Confidence Interval NA to NA | Months | |
| Progression-Free Survival(PFS) | Placebo | 19.2 | 95% Confidence Interval NA to NA | Months | |
| Objective Response Rate (ORR) | Vandetanib 300 mg | 104 | Participants | ||
| Objective Response Rate (ORR) | Placebo | 13 | Participants | ||
| Disease Control Rate (DCR) | Vandetanib 300 mg | 200 | Participants | ||
| Disease Control Rate (DCR) | Placebo | 71 | Participants | ||
| Duration of Response (DoR) | Vandetanib 300 mg | 22.2 | 95% Confidence Interval NA to NA | Months | |
| Duration of Response (DoR) | Placebo | 16.3 | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | Vandetanib 300 mg | 81.6 | 95% Confidence Interval 64.6 to 98.5 | Months | |
| Overall Survival (OS) | Placebo | 80.4 | 95% Confidence Interval 52.5 to NA | Months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Treatment Period | STARTED | Vandetanib 300 mg/Vandetanib 300 mg | 231 | |
| Randomized Treatment Period | STARTED | Placebo/Vandetanib 300 mg | 100 | |
| Randomized Treatment Period | Received Randomized Treatment | Vandetanib 300 mg/Vandetanib 300 mg | 231 | |
| Randomized Treatment Period | Received Randomized Treatment | Placebo/Vandetanib 300 mg | 99 | |
| Randomized Treatment Period | COMPLETED | Vandetanib 300 mg/Vandetanib 300 mg | 14 | |
| Randomized Treatment Period | COMPLETED | Placebo/Vandetanib 300 mg | 1 | |
| Randomized Treatment Period | NOT COMPLETED | Vandetanib 300 mg/Vandetanib 300 mg | 217 | |
| Randomized Treatment Period | NOT COMPLETED | Placebo/Vandetanib 300 mg | 99 | |
| Open-Label Treatment Period | STARTED | Vandetanib 300 mg/Vandetanib 300 mg | 109 | |
| Open-Label Treatment Period | STARTED | Placebo/Vandetanib 300 mg | 79 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events1,188
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 | Vertigo | Ear and labyrinth disorders | Randomized Treatment Period: Vandetanib 300 mg | 10 | 231 | 12 |
| other | Vertigo | Ear and labyrinth disorders | Randomized Treatment Period: Placebo | 2 | 99 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg | 1 | 109 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Open-Label Treatment Period: Placebo/Vandetanib 300 mg | 5 | 79 | 5 |
| other | Hypothyroidism | Endocrine disorders | Randomized Treatment Period: Vandetanib 300 mg | 16 | 231 | 19 |
| other | Hypothyroidism | Endocrine disorders | Randomized Treatment Period: Placebo | 0 | 99 | 0 |
| other | Hypothyroidism | Endocrine disorders | Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg | 1 | 109 | 1 |
| other | Hypothyroidism | Endocrine disorders | Open-Label Treatment Period: Placebo/Vandetanib 300 mg | 1 | 79 | 1 |
| other | Corneal Opacity | Eye disorders | Randomized Treatment Period: Vandetanib 300 mg | 11 | 231 | 11 |
| other | Corneal Opacity | Eye disorders | Randomized Treatment Period: Placebo | 0 | 99 | 0 |
1 to 10 of 1,188Source ClinicalTrials.gov
See all 1,188 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomized Treatment Period: Vandetanib 300 mg | 66 | 231 |
| Total, all-cause mortality | Randomized Treatment Period: Placebo | 10 | 100 |
| Total, all-cause mortality | Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg | 52 | 109 |
| Total, all-cause mortality | Open-Label Treatment Period: Placebo/Vandetanib 300 mg | 41 | 79 |
| Total, other adverse events | Randomized Treatment Period: Vandetanib 300 mg | 226 | 231 |
| Total, other adverse events | Randomized Treatment Period: Placebo | 87 | 99 |
| Total, other adverse events | Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg | 32 | 109 |
| Total, other adverse events | Open-Label Treatment Period: Placebo/Vandetanib 300 mg | 70 | 79 |
| Total, serious adverse events | Randomized Treatment Period: Vandetanib 300 mg | 92 | 231 |
| Total, serious adverse events | Randomized Treatment Period: Placebo | 16 | 99 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22025146 | RESULT |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vandetanib 300 mg vs Placebo: Biochemical Response Carcinoembryonic Antigen (CEA) | Trial comparisons |
| Vandetanib 300 mg vs Placebo: Biochemical Response Calcitonin (CTN) | Trial comparisons |
| Vandetanib 300 mg vs Placebo: Disease Control Rate (DCR) | Trial comparisons |
| Vandetanib 300 mg vs Placebo: Objective Response Rate (ORR) | 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/NCT00410761
GET https://conductscience.org/api/trials/v1/NCT00410761/events?page=2