Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06458036 | Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE) | PHASE2 | RECRUITING | 13 | — | — | Jul 29, 2024 | Nov 1, 2031 | Apr 15, 2026 | 4 | United States |
Determine the overall, pulmonary, structural, and biochemical response rate to selpercatinib in patients with RET fusion differentiated thyroid cancer treated with 6 months of selpercatinib prior to 131I therapy
Determine the progression free survival to the combination of selpercatinib followed 6 months later 131I therapy from the initiation of selpercatinib therapy
Determine the proportion of patients for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.
Determine the safety of the combination of selpercatinib given for 6-months followed by 131I therapy in patients with RET fusion differentiated thyroid cancer
| Arm | Type | Description |
|---|---|---|
| Experimental: Selpercatinib Monotherapy with 131I Therapy | EXPERIMENTAL | Patients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose. Patients will receive 131I therapy after 6 months of selpercatinib. Selpercatinib will be continued for 5 days after RAI therapy and then patients will enter a wait and see period off treatment. Patients who experience disease progression at any point while on selpercatinib will proceed to 131I therapy and discontinue selpercatinib. |
| Name | Type | Description |
|---|---|---|
| Selpercatinib Monotherapy | DRUG | Patients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose. |
| 131I Therapy | RADIATION | Patients will receive 131I therapy after 6 months of selpercatinib. |
Inclusion Criteria: 1. Age 2-25 years, inclusive 2. Histologic diagnosis of a differentiated thyroid cancer, status post thyroidectomy and adequate local therapy (e.g., lymph node dissection as per standard of care) for metastatic disease in the neck in the opinion of the treating investigator 3. A...