Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04554680
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2020-08-29
Brief Title:
Clinical Trial in RAI-Refractory Thyroid Carcinoma Evaluating BRAF MEK Blockade for Re-differentiation Therapy
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Phase II Clinical Trial in Radioactive Iodine-Refractory Advanced Thyroid Carcinoma Evaluating BRAF MEK Blockade Therapy for Re-differentiation- Applying a Novel Time-Dependent Concept
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
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:
Progressive and metastatic thyroid cancer patients who no longer respond to radioactive iodine RAI are currently treated with long term tyrosine kinase inhibitors to control tumor growth The investigators will study the effect of short term oral anti-cancer drug combination called dabrafenib BRAF inhibitor and trametinib MEK inhibitor in improving thyroid cancer RAI absorption that can potentially lead to tumor shrinkage response To assess for suitability participants thyroid cancer tissue taken at the time of surgery will be tested for DNA changes such as BRAFV600E RAS or MEK mutations
Based on experimental studies the response to these medications could occur within 1 week of treatment So in the study the investigators will find out whether participants cancer would respond to 1 week of treatment with these medications rather than the 1 month duration of treatment in previous re-differentiation clinical trials After 1 week of treatment with dabrafenib and trametinib iodine absorption I-124 PET-CT scan will predict if the cancer will respond to RAI If iodine absorption is insufficient on the scan treatment with dabrafenib and trametinib will be continued for a total of 4 weeks Then iodine absorption response of participants cancer will be assessed on I-124 PET-CT scan again If the iodine absorption is good at 1 week or 4 weeks the investigators will treat the participant with thyroid cancer using RAI
The 1-week treatment regime can potentially save cost avoid drug toxicity with prolonged treatment and prevent drug resistance that can occur with longer treatment period
Based on experimental studies the response to these medications could occur within 1 week of treatment So in the study the investigators will find out whether participants cancer would respond to 1 week of treatment with these medications rather than the 1 month duration of treatment in previous re-differentiation clinical trials After 1 week of treatment with dabrafenib and trametinib iodine absorption I-124 PET-CT scan will predict if the cancer will respond to RAI If iodine absorption is insufficient on the scan treatment with dabrafenib and trametinib will be continued for a total of 4 weeks Then iodine absorption response of participants cancer will be assessed on I-124 PET-CT scan again If the iodine absorption is good at 1 week or 4 weeks the investigators will treat the participant with thyroid cancer using RAI
The 1-week treatment regime can potentially save cost avoid drug toxicity with prolonged treatment and prevent drug resistance that can occur with longer treatment period
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 202000309 | OTHER | NHG DSRB Reference | None |