A Phase II Study of Efatutazone, an Oral PPAR Agonist, in Combination with Paclitaxel in Patients with Advanced Anaplastic Thyroid Cancer.

Research & Trial Information

SCHEMA A091305

Protocol #: A091305

Cancer Type: Head and Neck Thyroid

Eligibility Criteria:

  1. Patients must have histologically or cytologically diagnosed advanced ATC.
  2. Patients must have Measurable disease.
  3. Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB).
  4. Patients should have resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade 1.
  5. There is no limit to the number of prior lines of treatment a patient has received.
  6. No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) ≤ 21 days before study registration.
  7. No prior taxane therapy ≤ 6 months, except as a radiosensitizer.
  8. No history of the following:Class III or IV congestive heart failure (CHF).

    • Grade 3 or 4 thromboembolic event < 6 months.

    Pericardial effusion < 12 months (any grade).

    Pericardial involvement with tumor.

    • Grade 2 or higher pleural effusion < 6 months.

  9. No current symptomatic, untreated, or uncontrolled brain metastases present.
  10. No major surgery < 14 days prior to registration.
  11. No grade 2 or higher neuropathy.
  12. No known history of severe hypersensitivity reactions to any of the components of efatutazone or paclitaxel formulations.
  13. Age ≥ 18 years.
  14. Concomitant Medications:Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible.

    • Patients with known hypersensitivity to any TZD oral agents are not eligible.

  15. ECOG Performance Status ≤2.



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