A Phase I Clinical and Pharmacokinetic Study of SB939 in Patients With Advanced Cancer
OBJECTIVES:
Primary
- To determine the recommended phase II dose of oral SB939 in patients with solid tumors.
Secondary
- To determine the toxic effects of SB939 and its association with dose and
pharmacokinetics.
- To assess the pharmacokinetic profile of SB939.
- To assess preliminary evidence of antitumor effects of SB939 in patients with
measurable disease as documented by objective response.
- To establish proof-of-principle for SB939 effects on histone acetylation by evaluation
of histone acetylation and other biomarkers in peripheral blood mononuclear cells
(PBMCs) at all dose levels.
OUTLINE: Patients receive oral SB939 once daily on days 1-5 and 15-19. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity.
Patients undergo blood sample collection periodically during course 1 for pharmacokinetic
and pharmacodynamic studies. Samples are analyzed for levels of SB939 via LC-MS/MS method
and levels of acetylated histone 3 (AcH3), target effect, downstream consequences, and tumor
response via western blot, immunohistochemistry, or ELISA methods.
After completion of study treatment, patients are followed at 4 weeks and then every 3
months thereafter.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose
Assess for safety, tolerability, toxicity profile and dose limiting toxicities
Each dose level
Yes
Lillian L. Siu, MD, FRCPC
Study Chair
Princess Margaret Hospital, Canada
Canada: Health Canada
I188
NCT00504296
June 2007
June 2011
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