Status:
WITHDRAWN
Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias
Lead Sponsor:
Astex Pharmaceuticals, Inc.
Conditions:
Relapsed/Refractory Leukemias
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Dose escalation study for subjects with Leukemia that has returned or has not responded to standard treatment.
Detailed Description
A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects with Relapsed/Refractory Leukemias
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01239108
Start Date
October 1 2010
End Date
April 1 2012
Last Update
August 2 2024
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States