A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis

S*BIO

Status and phase

Completed

Phase 2

Phase 1

Conditions

Myelofibrosis

Polycythemia Vera

Myeloproliferative Disorders

Essential Thrombocythemia

Treatments

Drug: SB1518

Study type

Interventional

Funder types

Industry

Identifiers

NCT00745550

SB1518-2008-003

Details and patient eligibility

About

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 single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis (CIMF) regardless of their JAK2 mutational status. 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 CIMF.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)