During the Phase 1 and Phase 2 portions of the study, subject eligibility criteria are
identical except for prior treatment for ATC. During Phase 1, eligible subjects may have
received prior chemotherapy while during Phase 2, eligible subjects 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

- Neither pregnant nor breastfeeding

Exclusion Criteria:

- No medical history of diabetes mellitus requiring treatment with insulin or oral
agents; no pleural or pericardial effusion or clinically significant pulmonary or
cardiovascular disease.

- No clinically active brain metastasis, uncontrolled seizure disorder, spinal cord
compression, or carcinomatous meningitis

- No clinically significant active infection requiring antibiotic or antiretroviral
therapy

- No concomitant use of other TZDs