Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias
Study Details
Study Description
Brief Summary
Dose escalation study for subjects with Leukemia that has returned or has not responded to standard treatment.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects with Relapsed/Refractory Leukemias
Study Design
Outcome Measures
Primary Outcome Measures
- The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort [July 2011]
Secondary Outcome Measures
- • Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) • [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women with a confirmed diagnosis of leukemia unresponsive to curative therapy
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Eastern Cooperative Oncology Group performance status of 0 to 2
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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
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Normal cardiac function with left ventricular ejection fraction ≥ 50% at screening
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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)
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No reproductive potential or willing to use 2 methods of contraception during the study and for 30 days after the last dose
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Able to understand the purpose and risks of the study and provide informed consent and authorization to use protected health information
Exclusion Criteria:
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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
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Significant cardiovascular disease
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Malabsorption syndrome
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Symptomatic central nervous system metastases or lesions for which treatment is required
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Received prior radiation therapy within 4 weeks of first dose
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Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation
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Treatment with any investigational drug within 3 weeks of the first dose
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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
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Uncontrolled active systemic infections
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | MD Anderson Cancer Center | Houston | Texas | United States |
Sponsors and Collaborators
- Astex Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SGI-1776-02