Ignite Creation Date:
2024-05-06 @ 4:06 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02456701
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2015-05-20
Brief Title:
Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379
Sponsor:
Celldex Therapeutics
Organization:
Celldex Therapeutics
Study Overview
Official Title:
Enhancing Radioiodine RAI Incorporation Into BRAF Mutant RAI Refractory Thyroid Cancers With the Combination of BRAF Inhibitor Vemurafenib and Anti-ErbB3 Antibody KTN3379 A Pilot Study With a Phase 1 Run-in
Status:
COMPLETED
Status Verified Date:
2017-08
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 is a patient pilot study testing the hypothesis that vemurafenib with the addition of KTN3379 can restore iodine incorporation in BRAF mutant MUT radioiodine-refractory RAIR thyroid cancer patients
Detailed Description:
This is a patient pilot study testing the hypothesis that vemurafenib with the addition of KTN3379 can restore iodine incorporation in BRAF mutant MUT radioiodine-refractory RAIR thyroid cancer patients Eligible patients with BRAF MUT RAIR thyroid cancer will undergo human recombinant TSH rhTSH or Thyrogen-stimulated 124I PETCT lesional dosimetry to quantify the baseline RAI avidity of index metastatic lesions Patients will then receive vemurafenib followed by the addition of KTN3379 after which a second Thyrogen-stimulated 124I PETCT lesional dosimetry will be performed For patients whose tumors demonstrate sufficient iodine incorporation warranting 131I therapy Thyrogen-stimulated standard dosimetry will be performed and therapeutic 131I will be administered concurrently with vemurafenib and KTN3379 Subsequent to discontinuation of vemurafenib tumor assessments will be conducted with serial radiologic scans and thyroglobulins scans will be performed at baseline before 131I 3 months - 1 month following 131I and 6 months after 131I
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None