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Sponsored by: |
NCIC Clinical Trials Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00504296 |
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 | Intervention | 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 I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase I Clinical and Pharmacokinetic Study of SB939 in Patients With Advanced Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically or cytologically confirmed locally advanced or metastatic solid tumor
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Pathologic cardiac arrhythmia requiring active treatment
Inability to take oral medication
Pregnant or lactating women
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
At least 28 days since prior radiation therapy restricted to ≤ 30% of the bone marrow and recovered from toxic effects
Exclusion criteria:
Canada, Ontario | |
Margaret and Charles Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: Sebastien Hotte 905-387-9495 | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Lillian Siu 416-946-2911 |
Study Chair: | Lillian L. Siu, MD, FRCPC | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000558934, CAN-NCIC-IND188, S*BIO-SB939-2007-002 |
Study First Received: | July 17, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00504296 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |