Biomarker Phase II Study Of Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer.
- Conditions
- Advance Radioactive-Iodine Refractory Differentiated Thyroid CancerMedDRA version: 21.1Level: PTClassification code: 10066474Term: Thyroid cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-511292-15-00
- Lead Sponsor
- Grupo Espanol De Tumores Neuroendocrinos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 41
Male or female subjects = 18 years old., Female subjects of childbearing potential (WOCBP) must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%; refer to Appendix 5) for the duration of the study treatment and for 4 months after the final dose of cabozantinib. ? A woman is considered of childbearing potential ( i.e. fertile) following menarche and until becoming post-menopausal unless permanently sterile. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply: a. Amenorrheic for =1 year in the absence of chemotherapy and/or hormonal treatments b. Luteinizing hormone (LH) and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range c. Radiation induced oophorectomy with last menses >1 year ago d. Chemotherapy induced menopause with >1 year interval since last menses e. Surgical sterilization (bilateral oophorectomy or hysterectomy) f. Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy) g. Women =50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)., Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study treatment and for 4 months after the final dose of cabozantinib. ? A sterile male is defined as: a. One for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. b. Males with known low sperm counts” (consistent with sub-fertility”) are not to be considered sterile for purposes of this study., Capable of understanding and complying with the protocol requirements and signed informed consent., Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities., Histologically or cytologically confirmed diagnosis of DTC, including the following subtypes: (Note: results of a previous biopsy will be accepted): a. Papillary thyroid carcinoma (PTC) including histological variants of PTC such as follicular variant, tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated. b. Follicular thyroid carcinoma (FTC) including histological variants of FTC such as Hürthle cell, clear cell, insular, and poorly differentiated., Measurable disease according to RECIST 1.1 (Appendix 3) on computed tomography/magnetic resonance imaging (CT/MRI) performed within 28 days prior to first dose of study treatment., Must have been previously treated with or deemed ineligible for treatment with Iodine-131 for DTC., Must have been previously treated and experienced documented radiographic progression per RECIST 1.1 with one or two of the following VEGF-targeting
Prior treatment with any of the following: a. Cabozantinib. b. Selective small-molecule BRAF kinase inhibitor (eg, vemurafenib, dabrafenib). c. Immune checkpoint inhibitor therapy (eg, PD-1 or PD-L1 targeting agent). d. Systemic chemotherapy regimen (given as a single agent or in combination with another chemotherapy agent), Patients who are not able to swallow tablets., Previously identified allergy or hypersensitivity to components of the study treatment formulations., Diagnosis of another malignancy within 3 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy., Women pregnant or breastfeeding. Fertile and sexually active patients who are not willing to use the appropriate highly effective contraceptive methods., Any underlying medical or psychiatric disorder, which, in the opinion of the investigator, makes the administration of cabozantinib unsafe or interferes with the informed consent process or trial procedures., Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before first dose of study treatment., Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before first dose of study treatment., Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Patients with clinically relevant ongoing complications from prior radiation therapy that have not completely resolved are not eligible (eg, radiation esophagitis or other inflammation of the viscera)., Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of inclusion., Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel), except for the following allowed anticoagulants: a. Low-dose aspirin for cardioprotection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH). b. Anticoagulation with therapeutic doses of LMWH in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor., The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: a. Cardiovascular disorders: i. ii. iii. Congestive heart failure class 3 or 4 as defined by the New York Heart Association, unstable angina pectoris, serious cardiac arrhythmias. Uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment. Stroke (including transient ischemic attack [TIA]), myocardial infarction, or other ischemic event, or thromboembolic event (eg, deep venous thrombosis [DVT], pulmonary embolism) within 6 months before first dose of study treatment. Note: Patients with a more recent diagnosis of DVT are allowed if stable, asymptomatic, and treated with LMWH for at least 6 we
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method