Trial · NCT03690388
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
NCT03690388, Phase 3, Active not recruiting, Exelixis; results first posted 2023-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy. Trials, record NCT03690388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03690388
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
- NCT number
- NCT03690388
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 187 participants, actual
- Lead sponsor
- Exelixis
- Conditions
- Differentiated Thyroid Cancer
- Interventions
- Cabozantinib, Placebo
- First posted
- 2018-10-01
- Last updated
- 2026-10-20
- Results first posted
- 2023-05-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause. | Time to the earlier of either radiographic progressive disease (PD) or death from any cause. |
| Primary | Objective Response Rate (ORR) | Six months after 100 subjects are randomized. Time from randomization to best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BIRC per RECIST 1.1. | Proportion of subjects with the best overall response of complete response (CR) or partial response (PR). |
Source ClinicalTrials.gov
Outcomes2
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) | Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause. | All subjects randomized at the time of the analysis (N=187). | months | MEDIAN |
| PRIMARY | Objective Response Rate (ORR) | Six months after 100 subjects are randomized. Time from randomization to best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BIRC per RECIST 1.1. | The first 100 subjects randomized. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
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) | Cabozantinib | NA | 96% Confidence Interval 5.7 to NA | months | |
| Progression Free Survival (PFS) | Placebo | 1.9 | 96% Confidence Interval 1.8 to 3.6 | months | |
| Objective Response Rate (ORR) | Cabozantinib | 15 | 99% Confidence Interval 5.8 to 29.3 | percentage of participants | |
| Objective Response Rate (ORR) | Placebo | 0 | 99% Confidence Interval 0.0 to 14.8 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cabozantinib | 125 | |
| Overall Study | STARTED | Placebo | 62 | |
| Overall Study | COMPLETED | Cabozantinib | 89 | |
| Overall Study | COMPLETED | Placebo | 26 | |
| Overall Study | NOT COMPLETED | Cabozantinib | 36 | |
| Overall Study | NOT COMPLETED | Placebo | 36 |
Source ClinicalTrials.gov
Adverse events212
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 | Diarrhoea | Gastrointestinal disorders | Cabozantinib | 69 | 125 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 62 | |
| other | Nausea | Gastrointestinal disorders | Cabozantinib | 33 | 125 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 62 | |
| other | Vomiting | Gastrointestinal disorders | Cabozantinib | 18 | 125 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 5 | 62 | |
| other | Stomatitis | Gastrointestinal disorders | Cabozantinib | 20 | 125 | |
| other | Stomatitis | Gastrointestinal disorders | Placebo | 2 | 62 | |
| other | Constipation | Gastrointestinal disorders | Cabozantinib | 14 | 125 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 5 | 62 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cabozantinib | 17 | 125 |
| Total, all-cause mortality | Placebo | 14 | 62 |
| Total, other adverse events | Cabozantinib | 112 | 125 |
| Total, other adverse events | Placebo | 32 | 62 |
| Total, serious adverse events | Cabozantinib | 43 | 125 |
| Total, serious adverse events | Placebo | 18 | 62 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cabozantinib vs Placebo: deaths from any cause | Trial comparisons |
| Cabozantinib vs Placebo: serious adverse events | 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/NCT03690388
GET https://conductscience.org/api/trials/v1/NCT03690388/events?page=2