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

Primary Purpose

Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SB1518
Sponsored by
S*BIO
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring SB1518, Chronic Idiopathic Myelofibrosis, JAK2 Inhibitor

Eligibility Criteria

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

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.

Sites / Locations

  • The University of Chicago Hospitals
  • MD Anderson Cancer Center
  • Fred Hutchinson Cancer Center

Outcomes

Primary Outcome Measures

Phase 1: To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced myeloid malignancies
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose.

Secondary Outcome Measures

Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies
Assess the pharmacokinetic and pharmacodynamic profile of SB1518

Full Information

First Posted
July 20, 2008
Last Updated
April 19, 2012
Sponsor
S*BIO
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1. Study Identification

Unique Protocol Identification Number
NCT00719836
Brief Title
A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies
Official Title
A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S*BIO

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes, Myelofibrosis
Keywords
SB1518, Chronic Idiopathic Myelofibrosis, JAK2 Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB1518
Intervention Description
SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies
Time Frame
Throughout the study
Title
Assess the pharmacokinetic and pharmacodynamic profile of SB1518
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srdan Verstovsek, M.D, Ph.D
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
H. Joachim Deeg, M.D
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olatoyosi M. Odenike, M.D.
Organizational Affiliation
The University of Chicago Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27931243
Citation
Verstovsek S, Odenike O, Singer JW, Granston T, Al-Fayoumi S, Deeg HJ. Phase 1/2 study of pacritinib, a next generation JAK2/FLT3 inhibitor, in myelofibrosis or other myeloid malignancies. J Hematol Oncol. 2016 Dec 8;9(1):137. doi: 10.1186/s13045-016-0367-x.
Results Reference
derived

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

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