Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458036
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer RAISE
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Selpercatinib to Enhance RAI Avidity in Children Adolescents and Young Adults With Newly Diagnosed Differentiated Thyroid Cancers Harboring RET Fusions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAISE
Brief Summary:
Papillary thyroid cancer PTC is the most common form of differentiated thyroid cancer DTC The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine RAI therapy However less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies
Detailed Description:
This will be an open label non-randomized study to evaluate the efficacy and safety of the combination of selpercatinib followed by 131I therapy for patients with RET fusion differentiated thyroid cancer The primary Phase II objective will be to evaluate the pulmonary structural response rate at 18 months to the combination of selpercatinib given for 6-months followed by 131I therapy This is exempt from Investigational New Drug requirements per the FDA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None