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

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

Study Overview

• Status: Withdrawn
• Conditions: Relapsed/Refractory Leukemias
• Intervention / Treatment: Drug: SGI-1776

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
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort	July 2011

Secondary Outcome Measures

Outcome Measure	Time Frame
• Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) •	1 year

Collaborators and Investigators

• Sponsor: Astex Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 11, 2010

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: SGI-1776-02