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

Relapsed/Refractory Leukemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01239108
• Other study ID #: SGI-1776-02
• Status: Withdrawn
• Phase: Phase 1
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: January 2020
• Source: Astex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Relapsed/Refractory Leukemias

Intervention

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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Astex Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort		July 2011
Secondary	• Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) •		1 year