Phase I Study of SB939, an Oral HDAC Inhibitor in Advanced Solid Tumors
Author Information
Author(s): Razak A R A, Hotte S J, Siu L L, Chen E X, Hirte H W, Powers J, Walsh W, Stayner L-A, Laughlin A, Novotny-Diermayr V, Zhu J, Eisenhauer E A
Primary Institution: Princess Margaret Hospital
Hypothesis
The study aimed to determine the safety, dose-limiting toxicity, and pharmacokinetic and pharmacodynamic profiles of SB939 in patients with advanced solid tumors.
Conclusion
SB939 is well tolerated in patients with advanced solid tumors, with a recommended phase II dose of 60 mg given for 5 consecutive days every 2 weeks.
Supporting Evidence
- 38 patients received a total of 96 cycles of treatment.
- The most frequent non-hematologic adverse events were fatigue, nausea, vomiting, anorexia, and diarrhea.
- The recommended phase II dose was determined to be 60 mg.
- Pharmacokinetic analysis showed dose-proportional increases in AUC across the doses evaluated.
- Elimination half-life was found to be between 5.6 and 8.9 hours.
Takeaway
This study tested a new cancer drug called SB939 to see if it is safe and how well it works, and found that it can be taken without serious problems.
Methodology
Patients were enrolled in sequential dose-escalating cohorts to evaluate the safety and pharmacokinetics of SB939, with detailed blood sampling for pharmacokinetic analysis.
Limitations
The study did not observe any objective tumor responses, and the sample size was small, limiting the ability to draw definitive conclusions about efficacy.
Participant Demographics
{"median_age":62,"age_range":"20-88","sex_distribution":{"male":23,"female":15},"primary_tumor_sites":{"colon":15,"rectal":3,"neuroendocrine":3,"gastric":2,"head_and_neck":2,"non_small_cell_lung_cancer":2,"small_bowel_appendix":2,"cervix":1,"renal":1,"melanoma":1,"ovary":1,"prostate":1,"salivary_gland":1,"thyroid":1,"unknown_primary_others":2}}
Digital Object Identifier (DOI)
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