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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S*BIO
ClinicalTrials.gov Identifier:
NCT00745550
First received: September 2, 2008
Last updated: April 19, 2012
Last verified: April 2012
History of Changes

September 2, 2008
April 19, 2012
August 2008
January 2012   (final data collection date for primary outcome measure)
  • Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily. Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the maximum tolerated dose. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00745550 on ClinicalTrials.gov Archive Site
  • Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Assess the pharmacokinetic profile of SB1518 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Assess the pharmacodynamic profile of SB1518 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis

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.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myelofibrosis
  • Myeloproliferative Disorders
  • Polycythemia Vera
  • Essential Thrombocythemia
Drug: SB1518
SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
January 2012
January 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00745550
SB1518-2008-003
No
S*BIO
S*BIO
Not Provided
Principal Investigator: John Seymour, M.D. Peter MacCallum Cancer Centre, Australia
Principal Investigator: Andrew Roberts, M.D. Melbourne Health
Principal Investigator: Bik To, MD Royal Adelaide Hospital
Principal Investigator: Rami Komrokji, MD H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: Martha Wadleigh, MD Dana-Farber Cancer Institute
Principal Investigator: Ruben Mesa, MD Mayo Clinic
S*BIO
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP