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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
Phase 3 trial testing Cabozantinib in Differentiated Thyroid Cancer in 187 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Exelixis |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 187 |
| Start date | 5 October 2018 |
| Primary completion | 19 August 2020 |
| Estimated completion | 31 July 2026 |
| Sites | 164 locations across Hong Kong, Italy, Taiwan, Poland, South Korea, Croatia, Netherlands, Russia |
Exelixis — full company profile →
16 and older, any sex, with Differentiated Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to the earlier of either radiographic progressive disease (PD) or death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | NA | 5.7 – NA |
| Placebo | 1.9 | 1.8 – 3.6 |
Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 15 | 5.8 – 29.3 |
| Placebo | 0 | 0.0 – 14.8 |
Time frame: 1 year, 8 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cabozantinib | Placebo |
|---|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — | — |
| Disease progression | General disorders | — | — |
| General physical health deterioration | General disorders | — | — |
| Bone lesion | Musculoskeletal and connective tissue disorders | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| Pathological fracture | Musculoskeletal and connective tissue disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Laryngeal necrosis | Respiratory, thoracic and mediastinal disorders | — | — |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Ascites | Gastrointestinal disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Large intestine perforation | Gastrointestinal disorders | — | — |
| Reaction | System | Cabozantinib | Placebo |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — |
| Weight decreased | Investigations | — | — |
| Asthenia | General disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Mucosal inflammation | General disorders | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
Most-reported serious reactions: Pleural effusion, Pulmonary embolism, Dyspnoea, Diarrhoea, Thyroid cancer, Haemoptysis, Disease progression, General physical health deterioration.
Data from ClinicalTrials.gov NCT03690388 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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