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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


Phase 1
18 Years
70 Years
Not Enrolling
Both
Relapsed/Refractory Leukemias

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort

Outcome Time Frame:

July 2011

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

SGI-1776-02

NCT ID:

NCT01239108

Start Date:

October 2010

Completion Date:

April 2012

Related Keywords:

  • Relapsed/Refractory Leukemias
  • Leukemia

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096