A Phase 3 interventional study of Cabozantinib and Placebo in Differentiated Thyroid Cancer, sponsored by Exelixis. Active, not recruiting at 164 sites in 25 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Exelixis · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.
175 studies on the registry are indexed under Thyroid Cancer, Papillary; 52 are open to participants now.
This study's enrollment of 187 is above the median of 50 across 108 interventional studies indexed under Thyroid Cancer, Papillary.
Browse Thyroid Cancer, Papillary studies →Exelixis is the lead sponsor of 57 studies on the registry; 12 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
cabozantinib (60 mg) once daily orally (qd)
Drug: Cabozantinib
placebo once daily orally (qd)
Drug: Placebo
Tablets containing 60-mg or 20-mg cabozantinib once daily orally.
Also known as: XL184, Cabometyx®
Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.
Progression Free Survival (PFS)
Time to the earlier of either radiographic progressive disease (PD) or death from any cause.
Time frame: 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.
Objective Response Rate (ORR)
Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
Time frame: 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.
| Milestone | Cabozantinib | Placebo |
|---|---|---|
| Started | 125 | 62 |
| Completed | 89 | 26 |
| Not completed | 36 | 36 |
| Withdrew: Adverse event | 8 | 1 |
| Withdrew: Radiographic progression | 14 | 29 |
| Withdrew: Clinical deterioration | 10 | 6 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
Time to the earlier of either radiographic progressive disease (PD) or death from any cause.
| months | Cabozantinib | Placebo |
|---|---|---|
| Progression Free Survival (PFS) | NA (5.7 to NA) | 1.9 (1.8 to 3.6) |
Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
| percentage of participants | Cabozantinib | Placebo |
|---|---|---|
| Objective Response Rate (ORR) | 15 (5.8 to 29.3) | 0 (0.0 to 14.8) |
Collected over 1 year, 8 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cabozantinib | 17/125 (13.6%) | 43/125 (34.4%) | 112/125 (89.6%) |
| Placebo | 14/62 (22.6%) | 18/62 (29%) | 32/62 (51.6%) |
| Event | Cabozantinib | Placebo |
|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/125 | 4/62 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 4/125 | 3/62 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 4/125 | 0/62 |
| DiarrhoeaGastrointestinal disorders | 4/125 | 0/62 |
| Thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/125 | 0/62 |
| HydrothoraxRespiratory, thoracic and mediastinal disorders | 0/125 | 1/62 |
| PainGeneral disorders | 1/125 | 1/62 |
| Oedema peripheralGeneral disorders | 1/125 | 1/62 |
| Pain in jawMusculoskeletal and connective tissue disorders | 0/125 | 1/62 |
| PneumoniaInfections and infestations | 2/125 | 1/62 |
| Event | Cabozantinib | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 69/125 | 2/62 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 59/125 | 0/62 |
| FatigueGeneral disorders | 41/125 | 5/62 |
| HypertensionVascular disorders | 37/125 | 3/62 |
| NauseaGastrointestinal disorders | 33/125 | 1/62 |
| Decreased appetiteMetabolism and nutrition disorders | 33/125 | 10/62 |
| Alanine aminotransferase increasedInvestigations | 32/125 | 1/62 |
| Aspartate aminotransferase increasedInvestigations | 32/125 | 1/62 |
| HypocalcaemiaMetabolism and nutrition disorders | 30/125 | 1/62 |
| Weight decreasedInvestigations | 25/125 | 3/62 |
| Age, Categorical(Participants) | Cabozantinib | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 62 | 29 | 91 |
| >=65 years | 63 | 33 | 96 |
| Age, Continuous(years) | Cabozantinib | Placebo | Total |
|---|---|---|---|
| Median | 65 (32 to 85) | 66 (37 to 81) | 66 (32 to 85) |
| Sex: Female, Male(Participants) | Cabozantinib | Placebo | Total |
|---|---|---|---|
| Female | 68 | 34 | 102 |
| Male | 57 | 28 | 85 |
| Ethnicity (NIH/OMB)(Participants) | Cabozantinib | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 21 | 6 | 27 |
| Not Hispanic or Latino | 95 | 53 | 148 |
| Unknown or Not Reported | 9 | 3 | 12 |
| Race (NIH/OMB)(Participants) | Cabozantinib | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 0 | 3 |
| Asian | 20 | 14 | 34 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 90 | 41 | 131 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 11 | 5 | 16 |
| Region of Enrollment(participants) | Cabozantinib | Placebo | Total |
|---|---|---|---|
| Hong Kong | 0 | 1 | 1 |
| United States | 10 | 9 | 19 |
| Czechia | 1 | 0 | 1 |
| Thailand | 2 | 1 | 3 |
| Russia | 8 | 3 | 11 |
| Austria | 4 | 0 | 4 |
| Netherlands | 1 | 1 | 2 |
| South Korea | 8 | 8 | 16 |
| Brazil | 11 | 4 | 15 |
| Poland | 9 | 4 | 13 |
| France | 8 | 3 | 11 |
| Croatia | 1 | 0 | 1 |
| Argentina | 1 | 0 | 1 |
| Romania | 3 | 1 | 4 |
| Hungary | 5 | 3 | 8 |
| United Kingdom | 4 | 3 | 7 |
| Spain | 10 | 9 | 19 |
| Canada | 3 | 0 | 3 |
| Belgium | 3 | 2 | 5 |
| Taiwan | 6 | 3 | 9 |
| Italy | 14 | 5 | 19 |
| Mexico | 3 | 0 | 3 |
| Israel | 3 | 0 | 3 |
| Australia | 5 | 1 | 6 |
| Germany | 2 | 1 | 3 |
| Receipt of prior lenvatinib(Participants) | Cabozantinib | Placebo | Total |
|---|---|---|---|
| Count of participants | 79 | 39 | 118 |
Showing the first 100 of 164 sites across 25 countries.
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Plan to share: No
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Exelixis