Status:
COMPLETED
A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies
Lead Sponsor:
S*BIO
Conditions:
Acute Myelogenous Leukemia
Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00719836
Start Date
August 1 2008
End Date
January 1 2012
Last Update
April 20 2012
Active Locations (3)
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1
The University of Chicago Hospitals
Chicago, Illinois, United States, 60637
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109