Status:
COMPLETED
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
Lead Sponsor:
S*BIO
Conditions:
Myelofibrosis
Myeloproliferative Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The 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 s...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects with CIMF (including post ET/PV MF) requiring therapy, including:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Men of reproductive potential who can agree to practice effective contraception during the entire study period and for one month after the last study treatment
- Women of child-bearing potential who have a negative pregnancy test within 14 days prior to the first dose of study drug and can agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists
- Subjects who are able to understand and willing to sign the informed consent form
- Exclusion Criteria
- Subjects with 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 unless the antibiotic is a CYP3A4 inducer/inhibitor
- Subjects known to be HIV-positive
- Subjects with known active hepatitis A, B, or C, or latent hepatitis B
- Women who are pregnant or lactating
- Subjects with prior radiation therapy to more than 20% of the hematopoietic marrow (prior radiation to spleen is allowed)
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00745550
Start Date
August 1 2008
End Date
January 1 2012
Last Update
April 20 2012
Active Locations (6)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002