A Phase I Clinical and Pharmacokinetic Study of SB939 in Patients With Advanced Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- NCIC Clinical Trials Group
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- Recommended phase II dose
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SB939
Intervention: HDAC inhibitor SB939 (Drug)
SB939
Intervention: immunoenzyme technique (Other)
SB939
Intervention: immunohistochemistry staining method (Other)
SB939
Intervention: immunologic technique (Other)
SB939
Intervention: laboratory biomarker analysis (Other)
SB939
Intervention: liquid chromatography (Other)
SB939
Intervention: mass spectrometry (Other)
SB939
Intervention: pharmacological study (Other)
Outcomes
Primary Outcomes
Recommended phase II dose
Time Frame: Each dose level
Assess for safety, tolerability, toxicity profile and dose limiting toxicities
Secondary Outcomes
- Safety(Each dose level)
- SB939 effects on histone H3 acetylation(Cycle 1 days 1 and 15)
- Pharmacokinetic profile(Cycle 1 day 1 and 15)