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Completed

NCT Number: NCT00719836

A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

This study consists of two phases: the first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with advanced myeloid malignancies; the second portion of the study is a Phase 2 study to define the efficacy and safety profile of single-agent SB1518 at the recommended dose in subjects with chronic idiopathic myelofibrosis (CIMF).

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Key information

Conditions

Acute Myelogenous Leukemia Bone Marrow Diseases Chronic Disease Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelofibrosis Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Chicago Hospitals, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • During the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. This includes the following:
  • Subjects with Acute Myelogenous Leukemia (AML)
  • Subjects with Chronic Myelogenous Leukemia (CML) in accelerated phase
  • Subjects with Chronic Myelogenous Leukemia (CML) in blast crisis
  • Subjects with high-risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
  • Subjects with Advanced Myelofibrosis (MF)
  • In Phase 2, subjects with CIMF (as well as post ET/PV MF)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
  • Able to understand and willing to sign the informed consent form

Exclusion criteria

  • Subjects with Chronic Myelogenous Leukemia (CML) in chronic phase;
  • Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study;
  • Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study;
  • Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);
  • Known active hepatitis A, B, or C;
  • Women who are pregnant or lactating.

Treatment and study plan

SB1518

Drug

SB1518 taken orally daily for 28 consecutive days in a 28-day cycle

Primary outcomes

  1. Phase 1: To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced myeloid malignancies

    Time frame: Throughout the study

  2. Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose.

    Time frame: Throughout the study

Secondary outcomes

  1. Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies

    Time frame: Throughout the study

  2. Assess the pharmacokinetic and pharmacodynamic profile of SB1518

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

S*BIO

Industry

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2008
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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