Is NCT06440850 recruiting in Duarte, CA?

Yes, NCT06440850 is currently recruiting participants at its Duarte, CA location. This thyroid gland follicular carcinoma clinical trial is actively enrolling qualified participants.

How do I join the thyroid gland follicular carcinoma clinical trial in Duarte?

To join this clinical trial in Duarte, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Duarte clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Thyroid Gland Follicular Carcinoma Clinical Trial in Duarte, CA

About This Thyroid Gland Follicular Carcinoma Study in Duarte

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.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Willingness to be followed for about 14 months

Males or females aged ≥ 18 years at the time of informed consent

Patients with thyroid carcinoma of follicular origin (papillary, follicular or Hurthle cell)

Known positive BRAFV600E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples or on a biopsy sample)

High risk for recurrence according to the American Thyroid Association (ATA) guideline defined as having one or more of the features below:

Gross extrathyroidal extension

FTC with extensive vascular invasion (\> 4), although less likely to have BRAF mutation

PTC with vascular invasion

Advanced nodal disease of (any node \>3 cm, \> 4 nodes, or extra-nodal extension)

BRAF+TERT promoter mutation

Post op thyroglobulin (TG) suggestive of distant metastasis

Distant metastatic sites (only for exploratory arm)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Blood pressure (BP) ≤ 140/90 mm Hg at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to treatment start

Creatinine clearance ≥ 50 mL/min according to the Cockcroft and Gault formula

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

Hemoglobin ≥ 9.0 g/dL

Platelet count ≥ 100 x 109/L

Normal blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5

Bilirubin ≤ 1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome

Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if subject has liver metastases)

Women of childbearing potential must have a negative urine or serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment

Agreement by women of childbearing potential (WOCBP) and males of childbearing potential\

to use an effective\*\

method of birth control\*\

for at least 3 months prior to screening through 1 year of study follow-up.

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Effective birth control defined as hormonal and/or barrier contraception

Non-English speaking persons and adults lacking capacity to consent are not excluded from participation

Exclusion Criteria

Prior RAI treatment

Prior anti-BRAF, anti-MEK treatment such as sorafenib, dabrafenib, vemurafenib, encorafenib, binimetinib, cobimetinib, trametinib, d selumitinib and other TKIs like, lenvatinib, sunitinib, axitinib, cabozantenib, vandatinib, pazopanib use

Low to intermediate risk differentiated thyroid cancer (DTC) cases (not having the high-risk features as described above)

RAI contraindication

Undifferentiated or Medullary (MTC) carcinoma of the thyroid

Major surgery within 4 weeks prior to the first dose of treatment

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

External beam radiation, for thyroid cancer, \<4 weeks prior initiation of treatment

Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of the drugs

History of congestive heart failure greater or equal to than New York Heart association (NYHA) Class II, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of treatment, or cardiac arrhythmia associated with significant cardiovascular impairment and uncontrolled hypertension

Electrocardiogram (ECG) with QT interval (QTc) interval ≥ 480 msec

Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 2 months prior to the first dose of treatment and any other active bleeding, coagulopathy or pathologic condition that would confer a high risk of bleeding

Active infection requiring systemic therapy

Active malignancy (except for DTC, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months

Any history of or concomitant medical condition that, in the opinion of the investigator, would compromise subject's ability to safely complete the protocol

Females who are pregnant or breastfeeding

Patients with an injection of radio-contrast agent within 12 weeks prior to enrollment (can be enrolled after 12 weeks)

Previous history of retinal vein occlusion

Previous history of central serious retinopathy

Known hypersensitivity to the study drugs or to any of the excipients

Any other condition (including psychosocial condition) that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Any other condition that would confound study results

Noncompliance

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Duarte?

Yes, this clinical trial (NCT06440850) has an active research site in Duarte, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Thyroid Gland Follicular Carcinoma Treatment Options in Duarte, CA

If you're searching for thyroid gland follicular carcinoma treatment options in Duarte, CA, this clinical trial (NCT06440850) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Duarte research site is actively enrolling participants for this clinical trial. You'll receive care from experienced thyroid gland follicular carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all thyroid gland follicular carcinoma clinical trials near you to find additional studies recruiting in your area.

Thyroid Gland Follicular Carcinoma Clinical Trial in Duarte, CA

Expert Care in Duarte

IRB Approved

No-Cost Care

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