NCT00504296

SB939 in Treating Patients With Locally Advanced or Metastatic Solid Tumors

A Phase I Clinical and Pharmacokinetic Study of SB939 in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of SB939 in treating patients with locally advanced or metastatic solid tumors.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	HDAC inhibitor SB939	SB939 will be administered initially for 3 consecutive days every other week at the first dose level and then for 5 consecutive days every other week at escalating doses.
OTHER	immunoenzyme technique
OTHER	immunohistochemistry staining method
OTHER	immunologic technique
OTHER	laboratory biomarker analysis
OTHER	liquid chromatography
OTHER	mass spectrometry
OTHER	pharmacological study

Timeline

• Start date: 2007-09-14
• Primary completion: 2010-04-22
• Completion: 2011-06-21
• First posted: 2007-07-19
• Last updated: 2023-08-04

Locations

2 sites across 1 country: Canada