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New treatment option for BRAF NP_004324.2:p.V600E
Official title Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer
ClinicalTrials.gov ID: NCT03975231
What this study is testing
What is Dabrafenib?
Dabrafenib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for braf np_004324.2:p.v600e.
Also referred to as BRAF Inhibitor GSK2118436, GSK-2118436A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial studies how well dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) work together in treating patients with BRAF mutated anaplastic thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologic (histologic or cytologic) diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be ?consistent with anaplastic thyroid...
- Note: Tissue collection for central review is mandatory, but central review is not required for eligibility. Due to the aggressiveness of this...
- Presence of BRAF mutation (V600E or V600K) in tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
- Absolute neutrophil count \> 1,000/mcL.
You likely can't join if
- Patients with resectable stage IVA anaplastic thyroid cancer who are candidates for surgery and wish to proceed with surgery.
- Patients who have had external beam radiotherapy to neck or chest for cancer that would result in overlap of radiation therapy fields.
- Patients who have had cytotoxic chemotherapy, stereotactic brain radiation or external beam radiation within 2 weeks prior to study treatment...
- Patients who have had oral multikinase inhibitors within 1 week prior to study treatment initiation.
- Patients that have not recovered from adverse events related to prior therapy for cancer to Common Terminology Criteria for Adverse Events (CTCAE)...
- Patients previously treated with potent BRAF inhibitor or MEK inhibitor. Previous treatment with sorafenib is permitted.
See the full eligibility criteria
Who can join
- Pathologic (histologic or cytologic) diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be ?consistent with anaplastic thyroid cancer? with the presence of a thyroid mass is acceptable; pathology...
- Note: Tissue collection for central review is mandatory, but central review is not required for eligibility. Due to the aggressiveness of this disease, treatment will be started prior to central review.
- Presence of BRAF mutation (V600E or V600K) in tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
- Absolute neutrophil count \> 1,000/mcL.
- Hemoglobin \>= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] \>= 9.0 g/dl is acceptable).
- Platelets \> 75,000/mcL.
- Total bilirubin \< 1.5 x institutional upper limit of normal (unless due to Gilbert?s disease).
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) \< 2.5 x institutional upper limit of normal.
- Serum creatinine \< 1.5 x institutional upper limit of normal.
- Female patients of childbearing potential are required to have a negative serum pregnancy test within 14 days prior to the first dose of study medication.
- Females are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and for 4 months after the last dose of study medication. Should a woman...
- Specific contraception requirements for females: Female people of childbearing potential must not become pregnant and are required to be sexually inactive by abstinence or use contraceptive methods with a failure rate...
- Intrauterine device (IUD) or intrauterine system (IUS) that meets the \< 1% failure rate as stated in the product label,
- Male partner sterilization (vasectomy with documentation of Azoospermia) prior to the female subject's entry into the study, and this male is patient?s sole sexual partner. For this definition, ?documented? refers to...
- Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam, gel, film, cream, suppository) These allowed methods of contraception are only effective when used...
- Specific contraception requirements for males: To prevent pregnancy in a female partner or to prevent exposure of any partner to the investigational product from a male subject?s semen, male people must use one of the...
- Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject for 14 days prior to first dose of study drug, through the dosing period, and for at least 16 weeks after the...
- Condom (during non-vaginal intercourse with any partner - male or female) OR
- Condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) (during sexual intercourse with a female).
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Patients with resectable stage IVA anaplastic thyroid cancer who are candidates for surgery and wish to proceed with surgery.
- Patients who have had external beam radiotherapy to neck or chest for cancer that would result in overlap of radiation therapy fields.
- Patients who have had cytotoxic chemotherapy, stereotactic brain radiation or external beam radiation within 2 weeks prior to study treatment initiation.
- Patients who have had oral multikinase inhibitors within 1 week prior to study treatment initiation.
- Patients that have not recovered from adverse events related to prior therapy for cancer to Common Terminology Criteria for Adverse Events (CTCAE) 4.03 grade 2 or less except for alopecia.
- Patients previously treated with potent BRAF inhibitor or MEK inhibitor. Previous treatment with sorafenib is permitted.
- Patients that are receiving any other investigational agent.
- Patients that are currently taking any prohibitive medication.
- Patients with a history of other active malignancy requiring cancer treatment.
- Patients with uncontrolled brain metastases. Patients who are on a stable dose of corticosteroids for more than 1 week or off corticosteroids for 2 weeks prior to study enrollment can be enrolled. Enzyme-inducing...
- Patients with a known history of retinal vein occlusion (RVO), central serous retinopathy (CSR), uncontrolled glaucoma or ocular hypertension.
- Patients with class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Corrected QT (QTc) interval greater than or equal to 480 msecs (\>= 500 msec for people with Bundle Branch Block).
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac...
- Pregnant women and nursing women are excluded from this study because dabrafenib has the potential for teratogenic or abortifacient effects. In embroyfetal developmental studies in rats, developmental toxicities...
- Known human immunodeficiency virus (HIV)-positive patients or those on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Columbus, Ohio, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.