A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel

A Phase 1/2 Study of CS7017, an Oral PPARγ Agonist, in Combination With Paclitaxel in Subjects With Advanced Anaplastic Thyroid Cancer

The Phase I/II study will be conducted as an open label, multiple center study of CS-7017, an experimental drug and paclitaxel chemotherapy in subjects with advanced anaplastic thyroid cancer. Biopsies will be obtained from patients with accessible tumor at baseline, two-weeks after the first CS-7017 dosage (prior to the start of combination therapy) and at the end of the first study cycle (week 3 of combination therapy), in order to evaluate the effects of the study drug alone and in combination with the chemotherapy agent on the tumor. Treatment will continue until disease progression or the development of intolerable toxicities.

During the Phase 1 and Phase 2 portions of the study, participant eligibility criteria are identical except for prior treatment for anaplastic thyroid cancer (ATC). During Phase 1, eligible participants may have received prior chemotherapy while during Phase 2, eligible participants must be chemotherapy naïve.

Inclusion Criteria:

• Histologically or cytologically diagnosed, advanced ATC
• Measurable lesion(s)
• Lesion(s) (primary or metastatic) with viable tumor tissue accessible for repeated biopsy
• Age equal to or older than 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Adequate organ and bone marrow function
• Agreement to use effective contraception while on treatment and for equal to or greater than 3 months after end of treatment
• Pregnant or breastfeeding

Exclusion Criteria:

• Medical history of diabetes mellitus requiring treatment with insulin or oral agents; no pleural or pericardial effusion or clinically significant pulmonary or cardiovascular disease.
• Clinically active brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
• Clinically significant active infection requiring antibiotic or antiretroviral therapy
• Concomitant use of other thiazolidinediones (TZDs)