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

Study Overview
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Brief Summary
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Dose escalation study for subjects with Leukemia that has returned or has not responded to standard treatment.

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

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

Conditions
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Relapsed/Refractory Leukemias

Intervention / Treatment
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* Drug: SGI-1776


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with a confirmed diagnosis of leukemia unresponsive to curative therapy Eastern Cooperative Oncology Group performance status of 0 to 2 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 Normal cardiac function with left ventricular ejection fraction ≥ 50% at screening 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) No reproductive potential or willing to use 2 methods of contraception during the study and for 30 days after the last dose Able to understand the purpose and risks of the study and provide informed consent and authorization to use protected health information Exclusion Criteria: 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 Significant cardiovascular disease Malabsorption syndrome Symptomatic central nervous system metastases or lesions for which treatment is required Received prior radiation therapy within 4 weeks of first dose Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation Treatment with any investigational drug within 3 weeks of the first dose 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 Uncontrolled active systemic infections

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SGI-1776|SGI-1776 will be administered orally at escalating dose levels ranging from 350 to 1600 mg/day based on the dose escalation levels of the ongoing, first-in-human study.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort |  | July 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) • |  | 1 year |