SB939 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00504296|
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : June 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: HDAC inhibitor SB939 Other: immunoenzyme technique Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: pharmacological study||Phase 1|
- To determine the recommended phase II dose of oral SB939 in patients with solid tumors.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical and Pharmacokinetic Study of SB939 in Patients With Advanced Cancer|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||June 2011|
- 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
- Recommended phase II dose [ Time Frame: Each dose level ]Assess for safety, tolerability, toxicity profile and dose limiting toxicities
- Safety [ Time Frame: Each dose level ]Safety, tolerability, toxicity profile, dose limiting toxicities of SB939.
- Pharmacokinetic profile [ Time Frame: Cycle 1 day 1 and 15 ]Samples collected over multiple timepoints
- SB939 effects on histone H3 acetylation [ Time Frame: Cycle 1 days 1 and 15 ]Levels of AcH3 will be determined using wetern Blot, immunohistochemistry or Elisa method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504296
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Lillian L. Siu, MD, FRCPC||Princess Margaret Hospital, Canada|