A Phase I Dose Finding Study of an Experimental New Drug, PPAR Agonist Taken by Mouth by Patients With Advanced or Metastatic Cancer
- Histologically or cytologically diagnosed advanced or metastatic malignancy that is
refractory to, not curable with, or not eligible for standard treatment(s).
- 18 years or older
- ECOG performance status less than or equal to 2.
- Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE v3.0
grade less than or equal to 1.
- Adequate organ and bone marrow function.
- Willing to use effective contraceptive while on treatment through at least 3 months
- Negative pregnancy test for females of childbearing potential.
- Echocardiogram with EF within normal range.
- Anticipation of need for a major surgical procedure or radiation therapy during the
- Treatment with chemotherapy, hormonal therapy, other TZDs, radiotherapy, minor
surgery, or any investigational agent within 4 wks (6 wks for nitrosoureas, mitomycin
C, immunotherapy, biological therapy, or major surgery) of study treatment start.
- Patients with clinically significant pleural or pericardial effusion (patients with
minimal pleural effusion may be eligible at the Investigator's discretion).
- Clinically significant active infection, which requires antibiotic therapy, or
HIV-positive patients receiving antiretroviral therapy.