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NCT06440850 · ClinicalTrials.gov registry record · Phase 2
Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation
A Phase 2 study of Thyroid Gland Papillary Carcinoma and Thyroid Gland Follicular Carcinoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06440850: Recruiting Phase 2 study of Thyroid Gland Papillary Carcinoma and Thyroid Gland Follicular Carcinoma, sponsored by City of Hope Medical Center.
NCT06440850 is a Phase 2 study of Thyroid Gland Papillary Carcinoma and Thyroid Gland Follicular Carcinoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 21 participants, roughly in line with the 22-participant average among 3 other Thyroid Gland Papillary Carcinoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06440850, a Phase 2 study of Thyroid Gland Papillary Carcinoma and Thyroid Gland Follicular Carcinoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests how well vemurafenib and cobimetinib work in treating patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy. Vemurafenib and cobimetinib are used in patients whose cancer has a mutated (changed) form of a gene called BRAF. They are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving vemurafenib and cobimetinib may work better to treat patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy.
Primary Outcome
Excellent and indeterminate responses are defined by 2015 American Thyroid Association Management Guildelines for Differentiated Thyroid Cancer: * Excellent: Negative imaging and either suppresed thyroglobulin \< 0.2 ng/mL or TSH-stimulated thyroglobulin \< 1 ng/mL * Indeterminate: Nonspecific findings on imaging studies, faint uptake in thyroid bed on RAI scans, nonstimulated thyroglobulin detectable, but \<1 ng/mL, stimulated thyroglobulin detectable but \<10 ng/mL or thyroglobulin antibodies
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Diagnostic Imaging
- DRUG Cobimetinib
- PROCEDURE I-131 Uptake Test
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-07-15 |
| Est. Completion | 2026-11-22 |
| Phase | Phase 2 |
What NCT06440850 shows while recruiting
NCT06440850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, roughly in line with the 22-participant average among 3 other Thyroid Gland Papillary Carcinoma trials with a reported enrollment target.
The record links to 3 conditions, with Thyroid Gland Papillary Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06440850 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06440850 about?
NCT06440850 is a clinical study titled "Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation". This phase II trial tests how well vemurafenib and cobimetinib work in treating patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy. Vemurafenib and cobimetinib are used in patients whose cancer has a mutated (changed) form ...
What is the current status of trial NCT06440850?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2024-07-15. Estimated completion is 2026-11-22.
What conditions does trial NCT06440850 study?
This clinical trial studies the following conditions: Thyroid Gland Papillary Carcinoma, Thyroid Gland Follicular Carcinoma, Thyroid Gland Oncocytic Carcinoma.
What interventions are being tested in trial NCT06440850?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Diagnostic Imaging (PROCEDURE), Cobimetinib (DRUG), I-131 Uptake Test (PROCEDURE).
Who is sponsoring clinical trial NCT06440850?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06440850 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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