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

NCT01239108 | Withdrawn Phase 1

• 1 other identifier: SGI-1776-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed/Refractory Leukemias

Outcome Measures

Primary Outcomes (1)

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

  July 2011

Secondary Outcomes (1)

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

  1 year

Interventions

SGI-1776 DRUG

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astex Pharmaceuticals, Inc.: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

SGI 1776

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 11, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

US (1)