Trial · NCT01661179
Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma
NCT01661179, Phase 1, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2015-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma. Trials, record NCT01661179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01661179
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma
- NCT number
- NCT01661179
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma
- Interventions
- Vandetanib 300mg
- First posted
- 2012-08-09
- Last updated
- 2016-12-05
- Results first posted
- 2015-05-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib | Sept 2012 to May 2014 | ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (\>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib | Sept 2012 to May 2014 | All patients with post-baseline efficacy assessments | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib | Vandetanib 300 mg | 38.5 | 95% Confidence Interval 13.86 to 68.42 | percentage of 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 | Vandetanib 300 mg | 14 | |
| Overall Study | COMPLETED | Vandetanib 300 mg | 8 | |
| Overall Study | NOT COMPLETED | Vandetanib 300 mg | 6 |
Source ClinicalTrials.gov
Adverse events106
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 | Chalazion | Eye disorders | Vandetanib 300 mg | 1 | 14 | 1 |
| other | Corneal opacity | Eye disorders | Vandetanib 300 mg | 5 | 14 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | Vandetanib 300 mg | 1 | 14 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Vandetanib 300 mg | 1 | 14 | 1 |
| other | Gastritis | Gastrointestinal disorders | Vandetanib 300 mg | 1 | 14 | 1 |
| other | Haemorrhoidal haemorrhage | Gastrointestinal disorders | Vandetanib 300 mg | 1 | 14 | 1 |
| other | Nausea | Gastrointestinal disorders | Vandetanib 300 mg | 5 | 14 | 6 |
| other | Fatigue | General disorders | Vandetanib 300 mg | 3 | 14 | 5 |
| other | Non-cardiac chest pain | General disorders | Vandetanib 300 mg | 1 | 14 | 1 |
| other | Pyrexia | General disorders | Vandetanib 300 mg | 4 | 14 | 8 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib 300 mg | ||
| Total, other adverse events | Vandetanib 300 mg | 14 | 14 |
| Total, serious adverse events | Vandetanib 300 mg | 4 | 14 |
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 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/NCT01661179
GET https://conductscience.org/api/trials/v1/NCT01661179/events?page=2