Your session is about to expire
← Back to Search
Kinase Inhibitor
Vemurafenib + Cobimetinib for Thyroid Cancer
Phase 2
Recruiting
Led By Sasan Fazeli
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males or females aged ≥ 18 years at the time of informed consent
Patients with thyroid carcinoma of follicular origin (papillary, follicular or Hurthle cell)
Must not have
Subjects having > 1 + proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24 h will be ineligible
Need for locoregional treatment such as surgery, external beam radiation or thermoablation at inclusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year after treatment
Awards & highlights
Summary
This trial is testing how well vemurafenib and cobimetinib work in treating patients with high-risk thyroid cancer that has a specific genetic mutation. These medications work by blocking abnormal proteins that signal
Who is the study for?
This trial is for patients with high-risk differentiated thyroid carcinoma that has a specific BRAFV600E gene mutation. It's aimed at those preparing for radioactive iodine therapy.
What is being tested?
The effectiveness of vemurafenib and cobimetinib, both kinase inhibitors, is being tested to see if they can better prepare patients with the BRAFV600E mutation for radioactive iodine treatment by slowing cancer growth.
What are the potential side effects?
Possible side effects include fatigue, skin rash, joint pain, nausea, liver problems, heart issues, and vision changes due to the action of kinase inhibitors on abnormal proteins in cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My thyroid cancer is of follicular origin.
Select...
My cancer has a positive BRAFV600E mutation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My urine protein levels are below 1 g/24 h.
Select...
I need surgery or radiation therapy at the start of the trial.
Select...
I cannot undergo radioactive iodine treatment.
Select...
I have had serious heart issues or uncontrolled high blood pressure recently.
Select...
I have not had major surgery in the last 4 weeks.
Select...
I have not coughed up significant blood or had bleeding issues recently.
Select...
I am not pregnant or breastfeeding.
Select...
I have previously undergone radioactive iodine treatment.
Select...
I have taken medications like sorafenib or trametinib for cancer.
Select...
My thyroid cancer is of a specific type (undifferentiated or MTC).
Select...
I am currently on medication for an infection.
Select...
I have had a retinal vein occlusion before.
Select...
I have had central serious retinopathy in the past.
Select...
My thyroid cancer is not considered high risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one year after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patients who achieve excellent or indeterminate response with vemurafenib and cobimetinib treatment prior to radioactive iodine therapy
Secondary outcome measures
Incidence of treatment related adverse events
Progression free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (vemurafenib and cobimetinib)Experimental Treatment11 Interventions
Patients receive vemurafenib PO BID for 6 weeks and cobimetinib PO QD for 3 weeks, followed by 1 week off, and then continuing for 2 weeks. Patients then receive iodine 131 PO followed by 3 additional days of vemurafenib PO BID and cobimetinib PO QD. Patients receive thyrogen IM daily for 2 days followed by I-123 diagnostic scan during screening and on study. Patients also undergo MRI during screening, PET scan or CT scan and blood sample collection throughout the study and ultrasound imaging and I-131 whole body scan during follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Cobimetinib
2017
Completed Phase 3
~3300
Computed Tomography
2017
Completed Phase 2
~2740
Iodine I-131
2015
Completed Phase 2
~60
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Positron Emission Tomography
2011
Completed Phase 2
~2200
Ultrasound Imaging
2018
Completed Phase 4
~750
Vemurafenib
2015
Completed Phase 3
~3550
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,516 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,868 Total Patients Enrolled
Sasan FazeliPrincipal InvestigatorCity of Hope Medical Center
Share this study with friends
Copy Link
Messenger