Clinical trial · Interventional
SB939 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Phase I Clinical and Pharmacokinetic Study of SB939 in Patients With Advanced Cancer
NCT00504296CI-TRIAL-00068585completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDAC inhibitor SB939 | Drug | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| liquid chromatography | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SB939
- interventionNames
- 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
Primary outcomes (1)
- measure
- Recommended phase II dose
- timeFrame
- Each dose level
- description
- Assess for safety, tolerability, toxicity profile and dose limiting toxicities
Secondary outcomes (3)
- measure
- Safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically or cytologically confirmed locally advanced or metastatic solid tumor * Refractory to standard therapy or for which conventional therapy is not reliably effective Exclusion criteria: * Patients with documented CNS metastases PATIENT CHARACTERISTICS: Inclusion criteria: * 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 Exclusion criteria: * 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 * Inability to take oral medication * Patients must be able to swallow SB939 capsules and have no gastrointestinal abnormalities (e.g., bowel obstruction or previous gastric resection) which would lead to inadequate absorption of SB939 * Pregnant or lactating women * Urine or serum B-HCG must be negative * Women or men of child-bearing potential unless using effective contraception * Presence of any clinically significant co-morbidities (i.e., pulmonary disease, active CNS disease, or active infection) * Presence of any other significant CNS disorder that would hamper the patient's compliance * Presence of any significant psychiatric disorder that would hamper the patient's compliance * Other acute or chronic medical condition, psychiatric condition, or laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results * Pre-existing peripheral neuropathy ≥ grade 2 * Known HIV or hepatitis B or C infection PRIOR CONCURRENT THERAPY: Inclusion criteria: * Previous anticancer treatment must be discontinued at least 28 days prior to the first dose of study treatment (42 days \[6 weeks\] for nitrosoureas or mitomycin C) * At least 28 days since prior radiation therapy restricted to ≤ 30% of the bone marrow and recovered from toxic effects * Exceptions may be made for low-dose nonmyelosuppressive radiotherapy * Must be ≥ 14 days since any major surgery * Pre-existing bisphosphonate or luteinizing hormone-releasing hormone (LHRH) analog therapy (for men with hormone refractory prostate cancer) may be continued during study participation Exclusion criteria: * Previous treatment with a histone deacetylase (HDAC) inhibitor * Treatment with another investigational therapy within 28 days prior to study entry * Other concurrent anticancer treatment or investigational therapy * Concurrent agents with a known risk of Torsade de Pointes * Concurrent G-CSF, GM-CSF, or other hematopoietic growth factors may not be used as a substitute for a scheduled dose reduction (may be used in the management of acute toxicity)
References
Publications (1)
- RESULTRazak 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 21285985