Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759911
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2021-02-08
Brief Title:
Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Neoadjuvant Treatment with Selpercatinib in RET-Altered Thyroid Cancers
Status:
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:
None
Brief Summary:
This phase II trial studies the effect of selpercatinib given before surgery in treating patients with thyroid cancer whose tumors have RET alterations changes in the genetic material deoxyribonucleic acid DNA Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving selpercatinib before surgery may help shrink the tumors and help control the disease
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the efficacy of neoadjuvant selpercatinib in medullary thyroid cancer by objective response rate ORR per RECIST standard Response Evaluation Criteria in Solid Tumors RECIST
SECONDARY OBJECTIVES
I To evaluate the efficacy of neoadjuvant selpercatinib in medullary thyroid cancer by ORR per modified neck RECIST
II To evaluate the efficacy of neoadjuvant selpercatinib in medullary thyroid cancer per surgical margin status which is categorized as R0 R1 and R2 surgical resection
III To evaluate the safety profile of neoadjuvant selpercatinib
IV To evaluate the efficacy of neoadjuvant selpercatinib on progression-free survival PFS including overall PFS and locoregional PFS
V To measure changes in expected and actual surgical morbiditycomplexity as well as evaluate changes of R0R1 resection rates in pre-specified extrathyroidal anatomic target interfaces before and after selpercatinib treatment
EXPLORATORY OBJECTIVES
I In patients with differentiated thyroid cancer DTC and anaplastic thyroid cancer ATC only to evaluate the efficacy of neoadjuvant selpercatinib by ORR per RECIST standard RECIST and modified neck RECIST surgical margin status R0R1 versus vs R2 safety profile surgical morbiditycomplexity PFS and overall survival overall survival OS ATC only
II To define and measure changes of patient-reported outcomes and quality of life as measured by MD Anderson Symptom Inventory MDASI and European Quality of Life Five Dimension EQ-5D in patients with RET-altered thyroid cancer who receive selpercatinib treatment
III To explore translational endpoints in selpercatinib neoadjuvant therapy with biopsiestissue collection before selpercatinib treatment and during surgery
IV To explore peripheral and tissue measures associated with selpercatinib mechanisms of resistance in patients who experience disease progression after selpercatinib treatment
OUTLINE
Patients receive selpercatinb orally PO twice daily BID on days 1-28 Treatment repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity Patients then undergo standard of care surgery
After completion of study treatment patients are followed up for disease progression status every 3-4 months for the first 2 years ATC patients continue follow-up every 6 months for year 3 and 4 and once in year 5
I To evaluate the efficacy of neoadjuvant selpercatinib in medullary thyroid cancer by objective response rate ORR per RECIST standard Response Evaluation Criteria in Solid Tumors RECIST
SECONDARY OBJECTIVES
I To evaluate the efficacy of neoadjuvant selpercatinib in medullary thyroid cancer by ORR per modified neck RECIST
II To evaluate the efficacy of neoadjuvant selpercatinib in medullary thyroid cancer per surgical margin status which is categorized as R0 R1 and R2 surgical resection
III To evaluate the safety profile of neoadjuvant selpercatinib
IV To evaluate the efficacy of neoadjuvant selpercatinib on progression-free survival PFS including overall PFS and locoregional PFS
V To measure changes in expected and actual surgical morbiditycomplexity as well as evaluate changes of R0R1 resection rates in pre-specified extrathyroidal anatomic target interfaces before and after selpercatinib treatment
EXPLORATORY OBJECTIVES
I In patients with differentiated thyroid cancer DTC and anaplastic thyroid cancer ATC only to evaluate the efficacy of neoadjuvant selpercatinib by ORR per RECIST standard RECIST and modified neck RECIST surgical margin status R0R1 versus vs R2 safety profile surgical morbiditycomplexity PFS and overall survival overall survival OS ATC only
II To define and measure changes of patient-reported outcomes and quality of life as measured by MD Anderson Symptom Inventory MDASI and European Quality of Life Five Dimension EQ-5D in patients with RET-altered thyroid cancer who receive selpercatinib treatment
III To explore translational endpoints in selpercatinib neoadjuvant therapy with biopsiestissue collection before selpercatinib treatment and during surgery
IV To explore peripheral and tissue measures associated with selpercatinib mechanisms of resistance in patients who experience disease progression after selpercatinib treatment
OUTLINE
Patients receive selpercatinb orally PO twice daily BID on days 1-28 Treatment repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity Patients then undergo standard of care surgery
After completion of study treatment patients are followed up for disease progression status every 3-4 months for the first 2 years ATC patients continue follow-up every 6 months for year 3 and 4 and once in year 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0570 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-00535 | REGISTRY | None | None |