Trial · NCT00358956
A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer
NCT00358956, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2012-08-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer. Trials, record NCT00358956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00358956
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer
- NCT number
- NCT00358956
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Thyroid Cancer
- Interventions
- ZD6474 (vandetanib)
- First posted
- 2006-08-01
- Last updated
- 2017-01-30
- Other registries' IDs
- eudract:2006-001354-28
- Results first posted
- 2012-08-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. | 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 | Progression-Free Survival (PFS) | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. | Median progression free survival (months) estimated from a Weibull model with corresponding 95% confidence intervals. Progression free survival is the time 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. |
| Secondary | Disease Control Rate (DCR) | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. | 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) \>= 24 weeks |
| Secondary | World Heath Organization (WHO) Performance Status | WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment. | Number of patients demonstrating an improvement from baseline to 24 weeks in WHO PS. Where WHO PS is the standard scale with patients scored (0 healthy - 5 dead) based on their physical capabilities |
| Secondary | Symptomatic Response | Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment. | Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level. |
| Secondary | Biochemical Response Calcitonin (CTN ) | Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters) | A patient's best biochemical response was calculated from assessments performed 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. |
| Secondary | Biochemical Response Carcinoembryonic Antigen CEA) | Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation | A patient's best biochemical response was calculated from assessments performed 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 Partial Response (PR) or Complete Response (CR) were first met. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. | Participants | NUMBER | |
| SECONDARY | Progression-Free Survival (PFS) | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. | Months | MEDIAN | |
| SECONDARY | Disease Control Rate (DCR) | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. | Participants | NUMBER | |
| SECONDARY | World Heath Organization (WHO) Performance Status | WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment. | Participants | NUMBER | |
| SECONDARY | Symptomatic Response | Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment. | Participants | NUMBER | |
| SECONDARY | Biochemical Response Calcitonin (CTN ) | Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters) | Participants | NUMBER | |
| SECONDARY | Biochemical Response Carcinoembryonic Antigen CEA) | Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | ZD6474 (ZACTIMA™) 100 mg | 3 | Participants | ||
| Progression-Free Survival (PFS) | ZD6474 (ZACTIMA™) 100 mg | 16.2 | 95% Confidence Interval 6.8 to 38.6 | Months | |
| Disease Control Rate (DCR) | ZD6474 (ZACTIMA™) 100 mg | 13 | Participants | ||
| World Heath Organization (WHO) Performance Status | ZD6474 (ZACTIMA™) 100 mg | 0 | Participants | ||
| Symptomatic Response | ZD6474 (ZACTIMA™) 100 mg | 0 | Participants | ||
| Biochemical Response Calcitonin (CTN ) | ZD6474 (ZACTIMA™) 100 mg | 3 | Participants | ||
| Biochemical Response Carcinoembryonic Antigen CEA) | ZD6474 (ZACTIMA™) 100 mg | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ZD6474 (ZACTIMA™) 100 mg | 19 | |
| Overall Study | COMPLETED | ZD6474 (ZACTIMA™) 100 mg | 11 | |
| Overall Study | NOT COMPLETED | ZD6474 (ZACTIMA™) 100 mg | 8 |
Source ClinicalTrials.gov
Adverse events77
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 | Deafness Unilateral | Ear and labyrinth disorders | ZD6474 (ZACTIMA™) 100 mg | 1 | 19 | |
| other | Hypothyroidism | Endocrine disorders | ZD6474 (ZACTIMA™) 100 mg | 2 | 19 | |
| other | Conjunctivitis | Eye disorders | ZD6474 (ZACTIMA™) 100 mg | 1 | 19 | |
| other | Diplopia | Eye disorders | ZD6474 (ZACTIMA™) 100 mg | 1 | 19 | |
| other | Visual Disturbance | Eye disorders | ZD6474 (ZACTIMA™) 100 mg | 1 | 19 | |
| other | Diarrhoea | Gastrointestinal disorders | ZD6474 (ZACTIMA™) 100 mg | 9 | 19 | |
| other | Constipation | Gastrointestinal disorders | ZD6474 (ZACTIMA™) 100 mg | 4 | 19 | |
| other | Nausea | Gastrointestinal disorders | ZD6474 (ZACTIMA™) 100 mg | 3 | 19 | |
| other | Abdominal Pain | Gastrointestinal disorders | ZD6474 (ZACTIMA™) 100 mg | 2 | 19 | |
| other | Dyspepsia | Gastrointestinal disorders | ZD6474 (ZACTIMA™) 100 mg | 2 | 19 |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZD6474 (ZACTIMA™) 100 mg | ||
| Total, other adverse events | ZD6474 (ZACTIMA™) 100 mg | 18 | 19 |
| Total, serious adverse events | ZD6474 (ZACTIMA™) 100 mg | 4 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20371662 | BACKGROUND |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00358956
GET https://conductscience.org/api/trials/v1/NCT00358956/events?page=2