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

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ClinicalTrials.gov Identifier: NCT01239108
Recruitment Status : Withdrawn (The dose limiting toxicity of cardiac QTc prolongation was identified and demonstrated unsafe to continue clinical development of this molecule.)
First Posted : November 11, 2010
Last Update Posted : September 7, 2012
Information provided by:
Astex Pharmaceuticals

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
Relapsed/Refractory Leukemias Drug: SGI-1776 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias
Study Start Date : October 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort [ Time Frame: July 2011 ]

Secondary Outcome Measures :
  1. • Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) • [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239108

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
Sponsors and Collaborators
Astex Pharmaceuticals

Responsible Party: David S. Smith, Vice President-Regulatory and Quality Assurance, SuperGen, Inc.
ClinicalTrials.gov Identifier: NCT01239108     History of Changes
Other Study ID Numbers: SGI-1776-02
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: November 2010

Additional relevant MeSH terms:
Neoplasms by Histologic Type