SB939 in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: 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

• Registration Number: NCT00504296
• Lead Sponsor: NCIC Clinical Trials Group

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.

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 Timeline

• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-19
• Study Start: 2007-09-14
• Primary Completion: 2010-04-22
• Study Completion: 2011-06-21
• Status Verified: 2020-04
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SB939	HDAC inhibitor SB939	-
SB939	immunoenzyme technique	-
SB939	immunohistochemistry staining method	-
SB939	immunologic technique	-
SB939	laboratory biomarker analysis	-
SB939	liquid chromatography	-
SB939	mass spectrometry	-
SB939	pharmacological study	-

Primary Outcome Measures

Name	Time	Method
Recommended phase II dose	Each dose level	Assess for safety, tolerability, toxicity profile and dose limiting toxicities

Secondary Outcome Measures

Name	Time	Method
Safety	Each dose level	Safety, tolerability, toxicity profile, dose limiting toxicities of SB939.
SB939 effects on histone H3 acetylation	Cycle 1 days 1 and 15	Levels of AcH3 will be determined using wetern Blot, immunohistochemistry or Elisa method.
Pharmacokinetic profile	Cycle 1 day 1 and 15	Samples collected over multiple timepoints

Trial Locations

Locations (2)

Juravinski Cancer Centre at Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada