Trial · NCT01496313
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
NCT01496313, Phase 4, Completed, Sanofi; results first posted 2015-11-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer. Trials, record NCT01496313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01496313
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
- NCT number
- NCT01496313
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 81 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Thyroid Cancer
- Interventions
- 300mg vandetanib, 150mg vandetanib
- First posted
- 2011-12-21
- Last updated
- 2025-10-03
- Other registries' IDs
- eudract:2011-004701-24
- Results first posted
- 2015-11-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator | Randomisation to week 60 (maximum) | ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1 |
| Secondary | Best Objective Response | Randomisation to week 60 (maximum) | |
| Secondary | Duration of Objective Response (RECIST 1.1) by Treatment Arm | Randomization to Week 60 (maximum) | |
| Secondary | Time to Objective Response (RECIST 1.1) by Treatment Arm | Randomization to Week 60 (maximum) | |
| Secondary | Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm | Randomization to Week 60 (maximum) | |
| Secondary | Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm. | Week 3 to week 60 (maximum) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator | Randomisation to week 60 (maximum) | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; ORR = CR + PR | Proportion of participants | NUMBER |
| SECONDARY | Best Objective Response | Randomisation to week 60 (maximum) | Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD | Participants | NUMBER |
| SECONDARY | Duration of Objective Response (RECIST 1.1) by Treatment Arm | Randomization to Week 60 (maximum) | Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD | Months | MEDIAN |
| SECONDARY | Time to Objective Response (RECIST 1.1) by Treatment Arm | Randomization to Week 60 (maximum) | Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD | Months | MEDIAN |
| SECONDARY | Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm | Randomization to Week 60 (maximum) | Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD | % change | MEAN |
| SECONDARY | Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm. | Week 3 to week 60 (maximum) | All patients who received at least 1 dose of vandetanib and for whom quantifiable plasma concentration data were available. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator | Vandetanib 150 mg | 0.20 | 95% Confidence Interval 0.105 to 0.348 | Proportion of participants | |
| Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator | Vandetanib 300 mg | 0.29 | 95% Confidence Interval 0.176 to 0.445 | Proportion of participants | |
| Best Objective Response | Vandetanib 150 mg | Complete response | 0 | Participants | |
| Best Objective Response | Vandetanib 300 mg | Complete response | 1 | Participants | |
| Best Objective Response | Vandetanib 150 mg | Partial response | 8 | Participants | |
| Best Objective Response | Vandetanib 300 mg | Partial response | 11 | Participants | |
| Best Objective Response | Vandetanib 150 mg | Stable disease | 21 | Participants | |
| Best Objective Response | Vandetanib 300 mg | Stable disease | 23 | Participants | |
| Best Objective Response | Vandetanib 150 mg | Progressive disease | 9 | Participants | |
| Best Objective Response | Vandetanib 300 mg | Progressive disease | 2 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Period (up to 14 Months) | STARTED | Randomized Period: Vandetanib 150 mg | 40 | |
| Randomized Period (up to 14 Months) | STARTED | Randomized Period: Vandetanib 300 mg | 41 | |
| Randomized Period (up to 14 Months) | STARTED | Open-label Period: Vandetanib 100 mg | 0 | |
| Randomized Period (up to 14 Months) | STARTED | Open-label Period: Vandetanib 150 mg | 0 | |
| Randomized Period (up to 14 Months) | STARTED | Open-label Period: Vandetanib 200 mg | 0 | |
| Randomized Period (up to 14 Months) | STARTED | Open-label Period: Vandetanib 300 mg | 0 | |
| Randomized Period (up to 14 Months) | COMPLETED | Randomized Period: Vandetanib 150 mg | 35 | |
| Randomized Period (up to 14 Months) | COMPLETED | Randomized Period: Vandetanib 300 mg | 26 | |
| Randomized Period (up to 14 Months) | COMPLETED | Open-label Period: Vandetanib 100 mg | 0 | |
| Randomized Period (up to 14 Months) | COMPLETED | Open-label Period: Vandetanib 150 mg | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events936
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 | Randomized Period: Vandetanib 150 mg | 0 | 40 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Randomized Period: Vandetanib 300 mg | 2 | 41 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Open-label Period: Vandetanib 100 mg | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Open-label Period: Vandetanib 150 mg | 0 | 9 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Open-label Period: Vandetanib 200 mg | 1 | 8 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Open-label Period: Vandetanib 300 mg | 0 | 39 | 0 |
| other | Sinus Tachycardia | Cardiac disorders | Randomized Period: Vandetanib 150 mg | 0 | 40 | 0 |
| other | Sinus Tachycardia | Cardiac disorders | Randomized Period: Vandetanib 300 mg | 1 | 41 | 2 |
| other | Sinus Tachycardia | Cardiac disorders | Open-label Period: Vandetanib 100 mg | 0 | 5 | 0 |
| other | Sinus Tachycardia | Cardiac disorders | Open-label Period: Vandetanib 150 mg | 0 | 9 | 0 |
1 to 10 of 936Source ClinicalTrials.gov
See all 936 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomized Period: Vandetanib 150 mg | 1 | 40 |
| Total, all-cause mortality | Randomized Period: Vandetanib 300 mg | 6 | 41 |
| Total, all-cause mortality | Open-label Period: Vandetanib 100 mg | 0 | 5 |
| Total, all-cause mortality | Open-label Period: Vandetanib 150 mg | 0 | 9 |
| Total, all-cause mortality | Open-label Period: Vandetanib 200 mg | 1 | 8 |
| Total, all-cause mortality | Open-label Period: Vandetanib 300 mg | 10 | 39 |
| Total, other adverse events | Randomized Period: Vandetanib 150 mg | 38 | 40 |
| Total, other adverse events | Randomized Period: Vandetanib 300 mg | 40 | 41 |
| Total, other adverse events | Open-label Period: Vandetanib 100 mg | 5 | 5 |
| Total, other adverse events | Open-label Period: Vandetanib 150 mg | 7 | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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 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/NCT01496313
GET https://conductscience.org/api/trials/v1/NCT01496313/results?page=2