NCT00504296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2007

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 14, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2011

Completed
Last Updated

August 4, 2023

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

July 17, 2007

Last Update Submit

August 3, 2023

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Recommended phase II dose

    Assess for safety, tolerability, toxicity profile and dose limiting toxicities

    Each dose level

Secondary Outcomes (3)

  • Safety

    Each dose level

  • Pharmacokinetic profile

    Cycle 1 day 1 and 15

  • SB939 effects on histone H3 acetylation

    Cycle 1 days 1 and 15

Study Arms (1)

SB939

EXPERIMENTAL
Drug: HDAC inhibitor SB939Other: immunoenzyme techniqueOther: immunohistochemistry staining methodOther: immunologic techniqueOther: laboratory biomarker analysisOther: liquid chromatographyOther: mass spectrometryOther: pharmacological study

Interventions

HDAC inhibitor SB939DRUG

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.

SB939
immunoenzyme techniqueOTHER
SB939
immunohistochemistry staining methodOTHER
SB939
immunologic techniqueOTHER
SB939
laboratory biomarker analysisOTHER
SB939
liquid chromatographyOTHER
SB939
mass spectrometryOTHER
SB939
pharmacological studyOTHER
SB939

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed locally advanced or metastatic solid tumor
  • Refractory to standard therapy or for which conventional therapy is not reliably effective

You may not qualify if:

  • Patients with documented CNS metastases
  • PATIENT CHARACTERISTICS:
  • ECOG performance status of 0, 1, or 2
  • Must have a life expectancy of ≥ 12 weeks
  • Granulocytes (AGC) ≥ 1.5 x 10\^9/L
  • Platelets ≥ 100 x 10\^9/L
  • Bilirubin ≤ upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 x ULN (\< 5 x ULN if liver metastases are present)
  • Serum creatinine ≤ 1.2 x ULN OR creatinine clearance ≥ 60 mL/min
  • QTc ≤ 450 msec
  • LVEF ≥ 50% by ECHO or MUGA
  • Troponin I or T ≤ ULN
  • Must be within 1½ hour's driving distance
  • Pathologic cardiac arrhythmia requiring active treatment
  • Patients with a history of arrhythmia must be \> 12 months since last treatment with no recurrence of arrhythmia in the interval
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Razak AR, Hotte SJ, Siu LL, Chen EX, Hirte HW, Powers J, Walsh W, Stayner LA, Laughlin A, Novotny-Diermayr V, Zhu J, Eisenhauer EA. Phase I clinical, pharmacokinetic and pharmacodynamic study of SB939, an oral histone deacetylase (HDAC) inhibitor, in patients with advanced solid tumours. Br J Cancer. 2011 Mar 1;104(5):756-62. doi: 10.1038/bjc.2011.13. Epub 2011 Feb 1.

    PMID: 21285985RESULT

MeSH Terms

Interventions

SB939 compoundImmunoenzyme TechniquesImmunohistochemistryImmunologic TechniquesChromatography, LiquidMass Spectrometry

Intervention Hierarchy (Ancestors)

ImmunoassayInvestigative TechniquesMolecular Probe TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesChromatographyChemistry Techniques, Analytical

Study Officials

  • Lillian L. Siu, MD, FRCPC

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

September 14, 2007

Primary Completion

April 22, 2010

Study Completion

June 21, 2011

Last Updated

August 4, 2023

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)