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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Myelofibrosis, Myeloproliferative Disorders, Polycythemia Vera, Essential Thrombocythemia

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Trial Information

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

Inclusion 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily

Outcome Time Frame:

Throughout the study

Safety Issue:

Yes

Principal Investigator

John Seymour, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Human Research Ethics Committee

Study ID:

SB1518-2008-003

NCT ID:

NCT00745550

Start Date:

August 2008

Completion Date:

January 2012

Related Keywords:

  • Myelofibrosis
  • Myeloproliferative Disorders
  • Polycythemia Vera
  • Essential Thrombocythemia
  • SB1518
  • Chronic Idiopathic Myelofibrosis
  • Myeloproliferative disorders
  • Polycythemia Vera
  • Essential Thrombocythemia
  • JAK2 inhibitor
  • Primary Myelofibrosis
  • Myeloproliferative Disorders
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Mayo ClinicScottsdale, Arizona