Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias

Launched by ASTEX PHARMACEUTICALS, INC. · Nov 9, 2010

Keywords

ClinConnect Summary

A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects with Relapsed/Refractory Leukemias

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men and women with a confirmed diagnosis of leukemia unresponsive to curative therapy
• • 2. Eastern Cooperative Oncology Group performance status of 0 to 2
• • 3. Total bilirubin ≤ 1.5 X upper limit of normal (ULN); aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 3 X ULN; serum creatinine ≤ 2 X ULN
• • 4. Normal cardiac function with left ventricular ejection fraction ≥ 50% at screening
• • 5. No clinically significant abnormalities on screening electrocardiogram (ie, QTc interval must be \< 470 msec for women and \< 450 msec for men and no history of torsades de pointes)
• • 6. No reproductive potential or willing to use 2 methods of contraception during the study and for 30 days after the last dose
• • 7. Able to understand the purpose and risks of the study and provide informed consent and authorization to use protected health information
• Exclusion Criteria:
• • 1. A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral SGI-1776, or put the study outcomes at undue risk
• • 2. Significant cardiovascular disease
• • 3. Malabsorption syndrome
• • 4. Symptomatic central nervous system metastases or lesions for which treatment is required
• • 5. Received prior radiation therapy within 4 weeks of first dose
• • 6. Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation
• • 7. Treatment with any investigational drug within 3 weeks of the first dose
• • 8. Use of systemic corticosteroids (other than for premedications or intermittent doses such as those used for allergic reactions and control of asthma) or myelosuppressive chemotherapy within 2 weeks of the first dose treatment with nitrosoureas or mitomycin C within 3 weeks of the first dose of SGI 1776
• • 9. Uncontrolled active systemic infections