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

This study has been withdrawn prior to enrollment.
(The dose limiting toxicity of cardiac QTc prolongation was identified and demonstrated unsafe to continue clinical development of this molecule.)
Sponsor:
Information provided by:
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01239108
First received: November 5, 2010
Last updated: September 6, 2012
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Relapsed/Refractory Leukemias
Drug: SGI-1776
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias

Resource links provided by NLM:


Further study details as provided by Astex Pharmaceuticals:

Primary Outcome Measures:
  • The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort [ Time Frame: July 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) • [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: October 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239108

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
Sponsors and Collaborators
Astex Pharmaceuticals
  More Information

No publications provided

Responsible Party: David S. Smith, Vice President-Regulatory and Quality Assurance, SuperGen, Inc.
ClinicalTrials.gov Identifier: NCT01239108     History of Changes
Other Study ID Numbers: SGI-1776-02
Study First Received: November 5, 2010
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014