Trial · NCT00098345
Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
NCT00098345, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2011-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer. Trials, record NCT00098345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00098345
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
- NCT number
- NCT00098345
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Thyroid Cancer
- Interventions
- ZD6474 (vandetanib)
- First posted
- 2004-12-08
- Last updated
- 2018-05-07
- Results first posted
- 2011-05-24
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 | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. | 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) defined according to RECIST 1.0. |
| Secondary | Progression Free Survival | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. | Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. |
| Secondary | Duration of Objective Response | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. | Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days. |
| Secondary | Disease Control Rate | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. | Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0. |
| Secondary | Biochemical Response Calcitonin (CTN) | Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation | A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline). |
| Secondary | Symptomatic Response | Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug. | Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR. |
| Secondary | World Health Organisation (WHO) Performance Status | Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated. | Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled) |
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 | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. | Participants | NUMBER | |
| SECONDARY | Progression Free Survival | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. | Upper limit is a censored value | months | MEDIAN |
| SECONDARY | Duration of Objective Response | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. | days | MEDIAN | |
| SECONDARY | Disease Control Rate | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. | Participants | NUMBER | |
| SECONDARY | Biochemical Response Calcitonin (CTN) | Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation | Participants | NUMBER | |
| SECONDARY | Symptomatic Response | Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug. | Participants | NUMBER | |
| SECONDARY | World Health Organisation (WHO) Performance Status | Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated. | 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 | Caprelsa (Vandetanib) 300 mg | 6 | Participants | ||
| Progression Free Survival | Caprelsa (Vandetanib) 300 mg | 27.9 | Full Range 2.56 to 36.11 | months | |
| Duration of Objective Response | Caprelsa (Vandetanib) 300 mg | 310.5 | 95% Confidence Interval 245 to 402 | days | |
| Disease Control Rate | Caprelsa (Vandetanib) 300 mg | 22 | Participants | ||
| Biochemical Response Calcitonin (CTN) | Caprelsa (Vandetanib) 300 mg | 24 | Participants | ||
| Symptomatic Response | Caprelsa (Vandetanib) 300 mg | 0 | Participants | ||
| World Health Organisation (WHO) Performance Status | Caprelsa (Vandetanib) 300 mg | 4 | 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 | Caprelsa (Vandetanib) 300 mg | 30 | |
| Overall Study | COMPLETED | Caprelsa (Vandetanib) 300 mg | 17 | |
| Overall Study | NOT COMPLETED | Caprelsa (Vandetanib) 300 mg | 13 |
Source ClinicalTrials.gov
Adverse events128
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 | Caprelsa (Vandetanib) 300 mg | 3 | 30 | |
| other | Bradycardia | Cardiac disorders | Caprelsa (Vandetanib) 300 mg | 2 | 30 | |
| other | Palpitations | Cardiac disorders | Caprelsa (Vandetanib) 300 mg | 3 | 30 | |
| other | Tinnitus | Ear and labyrinth disorders | Caprelsa (Vandetanib) 300 mg | 2 | 30 | |
| other | Conjunctivitis | Eye disorders | Caprelsa (Vandetanib) 300 mg | 2 | 30 | |
| other | Dry Eye | Eye disorders | Caprelsa (Vandetanib) 300 mg | 2 | 30 | |
| other | Vision Blurred | Eye disorders | Caprelsa (Vandetanib) 300 mg | 7 | 30 | |
| other | Visual Disturbance | Eye disorders | Caprelsa (Vandetanib) 300 mg | 3 | 30 | |
| other | Abdominal Distension | Gastrointestinal disorders | Caprelsa (Vandetanib) 300 mg | 2 | 30 | |
| other | Abdominal Pain | Gastrointestinal disorders | Caprelsa (Vandetanib) 300 mg | 6 | 30 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Caprelsa (Vandetanib) 300 mg | 3 | 30 |
| Total, other adverse events | Caprelsa (Vandetanib) 300 mg | 30 | 30 |
| Total, serious adverse events | Caprelsa (Vandetanib) 300 mg | 14 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20065189 | 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/NCT00098345
GET https://conductscience.org/api/trials/v1/NCT00098345/events?page=2