Status and phase
Conditions
Treatments
About
Participants will have been diagnosed with advanced progressive thyroid cancer and are about to start treatment with a tyrosine kinase inhibitor (TKI).
The purpose of this study is to evaluate the efficacy and tolerability of tyrosine kinase inhibitor therapy (Lenvatinib or Sorafenib for differentiated thyroid cancer [which includes papillary thyroid cancer, follicular thyroid cancer, and poorly differentiated thyroid cancer]; and Cabozantinib or Vandetanib for medullary thyroid cancer) through adaptive (intermittent) versus conventional (continuous) regimen.
Full description
Population: Patients with advanced progressive 131I-refractory DTC or MTC will be enrolled to this study. Forty-five patients responding to TKI therapy (defined as 50% drop in tumor marker level within the first two months of treatment) will be randomized to receive TKI therapy either through adaptive (intermittent) or conventional (continuous) regimen.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
All histologically or cytologically confirmed diagnosis of thyroid cancer, other than anaplastic or stromal-cell derived cancers.
Participants with differentiated thyroid cancers (DTC) must have negative thyroglobulin antibodies.
Measurable disease meeting the following criteria and confirmed by central radiographic review:
Participants must show evidence of disease progression comparing (a) scan in screening and (b) historical scan obtained within 12 months prior to signing informed consent, according to RECIST 1.1 assessed and confirmed by central radiographic review of CT and/or MRI scans.
Participants with DTC must not be eligible for possible curative surgery and must be radioiodine (RAI)-refractory / resistant as defined by at least one of the following:
Participants with DTC must be receiving thyroxine suppression therapy and thyroid stimulating hormone (TSH) should not be elevated (TSH should be ≤ 0.1 mU/L).
"Measurable" tumor marker (non-stimulated thyroglobulin >10 ng/mL or CEA>10 ng/ML in patients with DTC; or serum basal calcitonin >10 pg/mL in patients with MTC)
Participants may have received prior multi-kinase targeted therapy except the TKI used in this trial. For example, patients getting Lenvatinib on this study may have been previously treated with Sorafenib, Vandetanib, Sunitinib, Pazopanib, etc. Each of the TKI targeted agents will be counted individually, regardless of the duration of its administration.
Participants with known brain metastases who have completed whole brain radiotherapy, stereotactic radiosurgery or complete surgical resection, will be eligible if they have remained clinically stable, asymptomatic for 30 days.
All chemotherapy or radiation related toxicities must have resolved to < Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE v 5.0), except alopecia infertility, anemia (see separate criteria) and any toxicities deemed irreversible by the treating physician.
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2.
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤ 150/90 mm Hg at screening and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1
Adequate renal function defined as calculated creatinine clearance ≥ 30 mL/min (using Cockcroft/Gault formula)
Adequate bone marrow function
Adequate liver function
Males or females age ≥ 18 years at the time of informed consent
Females must not be breastfeeding or pregnant at Screening or Baseline.
Males and females must follow all contraception guidelines as outlined in the protocol guidelines.
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
6 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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