Back to results

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

Primary Purpose

Relapsed/Refractory Leukemias

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SGI-1776

About this trial

This is an interventional treatment trial for Relapsed/Refractory Leukemias

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women with a confirmed diagnosis of leukemia unresponsive to curative therapy
Eastern Cooperative Oncology Group performance status of 0 to 2
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
Normal cardiac function with left ventricular ejection fraction ≥ 50% at screening
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)
No reproductive potential or willing to use 2 methods of contraception during the study and for 30 days after the last dose
Able to understand the purpose and risks of the study and provide informed consent and authorization to use protected health information

Exclusion Criteria:

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
Significant cardiovascular disease
Malabsorption syndrome
Symptomatic central nervous system metastases or lesions for which treatment is required
Received prior radiation therapy within 4 weeks of first dose
Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation
Treatment with any investigational drug within 3 weeks of the first dose
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
Uncontrolled active systemic infections

Sites / Locations

MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

• Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) •

Full Information

NCT ID

NCT01239108

First Posted

November 5, 2010

Last Updated

January 13, 2020

Sponsor

Astex Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01239108

Brief Title

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Withdrawn

Why Stopped

The dose limiting toxicity of cardiac QTc prolongation was identified and demonstrated unsafe to continue clinical development of this molecule.

Study Start Date

October 2010 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astex Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed/Refractory Leukemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

SGI-1776

Intervention Description

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 Measure Information:

Title

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

Time Frame

July 2011

Secondary Outcome Measure Information:

Title

• Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) •

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women with a confirmed diagnosis of leukemia unresponsive to curative therapy Eastern Cooperative Oncology Group performance status of 0 to 2 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 Normal cardiac function with left ventricular ejection fraction ≥ 50% at screening 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) No reproductive potential or willing to use 2 methods of contraception during the study and for 30 days after the last dose Able to understand the purpose and risks of the study and provide informed consent and authorization to use protected health information Exclusion Criteria: 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 Significant cardiovascular disease Malabsorption syndrome Symptomatic central nervous system metastases or lesions for which treatment is required Received prior radiation therapy within 4 weeks of first dose Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation Treatment with any investigational drug within 3 weeks of the first dose 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 Uncontrolled active systemic infections

Facility Information:

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs