progressed thyroid cancer
Conditions
Brief summary
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent radiology committee (BIRC), Objective response rate (ORR) per RECIST 1.1 by BIRC
Detailed description
Overall survival (OS), Duration of objective tumor response, Safety and tolerability, Pharmacokinetics (PK) of cabozantinib, Relationship of baseline and postbaseline changes in biomarkers, serum thyroglobulin (Tg), and circulating tumor cells (CTCs) and/or circulating DNA (ctDNA) with treatment and/or clinical outcome assessments may be performed, Change in mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and global health as assessed by the EuroQol Health questionnaire instrument (EQ-5D-5L), Health care resource utilization
Interventions
DRUGCabozantinib-matched placebo identical to the IMP apart from the active substance
Sponsors
Exelixis Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent radiology committee (BIRC), Objective response rate (ORR) per RECIST 1.1 by BIRC | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Duration of objective tumor response, Safety and tolerability, Pharmacokinetics (PK) of cabozantinib, Relationship of baseline and postbaseline changes in biomarkers, serum thyroglobulin (Tg), and circulating tumor cells (CTCs) and/or circulating DNA (ctDNA) with treatment and/or clinical outcome assessments may be performed, Change in mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and global health as assessed by the EuroQol Health questionnaire instrument (EQ-5D-5L), Health care resource utilization | — |
Countries
Poland, Romania, Spain
Outcome results
None listed