A Phase II Trial of Cabozantinib for the Treatment of Radioiodine (RAI)-Refractory Differentiated… (NCT02041260) | Clinical Trial Compass
UnknownPhase 2
A Phase II Trial of Cabozantinib for the Treatment of Radioiodine (RAI)-Refractory Differentiated Thyroid Carcinoma (DTC) in the First-line Setting
United States43 participantsStarted 2014-01
Plain-language summary
Phase II, non-randomized, open-label study to determine the efficacy of cabozantinib as a firstline treatment for patients with differentiated thyroid cancer (DTC). Subjects will receive drug at a starting dose of 60mg PO QD. Subjects can receive drug as long as they continue to derive clinical benefit or until they experience unacceptable drug-related toxicity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject has a histologic or cytologic diagnosis of a DTC tumor (including poorly differentiated thyroid cancer but not anaplastic thyroid cancer) that is metastatic or unresectable and fulfills the following criteria: a. Subjects must have progressive disease as defined by RECIST 1.1 criteria when comparing baseline scans to those obtained within the prior 14 months AND b. Subject must have RAIrefractory disease based on at least one of the following: i. Prior dose of RAI exceeding 600mCi ii.Progression of disease within 18 months following a dose of 100mCi iii. Presence of target lesions as defined by modified RECIST criteria which do not take up RAI.
* The subject has had an assessment of all known disease sites eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate, within 28 days before the first dose of cabozantinib
* The subject is 18 years old on the day of consent.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* The subject has organ and marrow function and laboratory values as follows within 4 days prior to the first dose of cabozantinib: a. Absolute neutrophil count (ANC) 1500/mm3without colony stimulating factor support b. Platelets 100,000/mm3 c. Hemoglobin 9 g/dL d.Bilirubin 1.5 the upper limit of normal (ULN). For subjects with known Gilberts disease, bilirubin 3.0mg/dL e. Serum albumin 2.0 g/dl f. Serum creatinine 1.5 ULN or creatinine clearan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.