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 range18 Years
SexALL
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…