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Clinical Trial 19442

Cancer Type: Head & Neck
Interventions:BAY 43-9006 (Sorafenib); Cabozantinib (XL 184); E7080 (Lenvatinib); Lenvatinib (Lenvima); Sorafenib; Vandetanib

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Christine Chung

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Adaptive Tyrosine Kinase Inhibitor Therapy In Patients With Advanced Progressive Thyroid Cancer

Summary

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.

Objective

Primary Objective: To evaluate the efficacy and tolerability of TKI therapy (Lenvatinib or Sorafenib for DTC; Cabozantinib or Vandetanib for MTC) through adaptive (intermittent) versus conventional (continuous) regimen. Secondary Objective: To compare toxicity of TKI therapy (Lenvatinib or Sorafenib for DTC; Cabozantinib or Vandetanib for MTC) through adaptive (intermittent) versus conventional (continuous) regimen. Exploratory Objective: Determine a predictive biomarkers of TKI response.

Inclusion Criteria

  • All histologically or cytologically confirmed diagnosis of thyroid cancer, other than anaplastic or stromal-cell derived cancers
  • Measurable disease 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.
  • 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 in patients with DTC; or serum basal calcitonin >10 pg/mL in patients with MTC)
  • Participants with DTC must have negative thyroglobulin antibodies.
  • 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 and off of steroids for one month.
  • All chemotherapy or radiation related toxicities must have resolved to > 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 bone marrow and liver
  • 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

  • Anaplastic thyroid carcinoma or stromal-cell derived carcinoma of the thyroid.
  • Any ongoing TKI treatments.
  • Prior treatment with the drug the patient will receive during the study.
  • Participants who have received any anticancer treatment (including Chinese herbal medicine specified for the treatment of tumor) within 21 days or any investigational agent within 30 days prior to the first dose of study drug. This does not apply to the use of TSH-suppressive thyroid hormone therapy.
  • Major surgery within 3 weeks prior to the first dose of study drug.
  • Participants having > 1 + proteinuria on urine dipstick testing (Participants with urine protein > Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of Lenvatinib, Sorafenib, Cabozantinib, or Vandetanib.
  • Significant cardiovascular impairment: history of (a) congestive heart failure greater than New York Heart association (NYHA) Class II, (b) unstable angina, (c) myocardial infarction, (d) stroke, or (e) cardiac arrhythmia associated with impairment within 6 months of the first dose of study drug.
  • Bleeding or thrombotic disorders (Treatment with low molecular weight heparin is allowed).
  • Radiographic evidence of major blood vessel invasion/infiltration.
  • Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
  • Active infection (any infection requiring systemic treatment).
  • Active malignancy (except for DTC/MTC or definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months.
  • Known intolerance to any of the study drugs (or any of the excipients).
  • Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
  • Pregnant or breastfeeding.
  • Taking prohibited medications outlined in protocol documentation.