Clinical trial NCT01239108: Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Relapsed/Refractory Leukemias
Lead sponsor: Astex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort
timeFrame: July 2011
Secondary outcomes:
measure: • Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) •
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: