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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
  Purpose

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.


Condition Intervention Phase
Myelofibrosis
Myeloproliferative Disorders
Polycythemia Vera
Essential Thrombocythemia
 Drug: SB1518
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by S*BIO:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB1518
    SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745550

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002
Australia
Royal Adelaide Hospital
Adelaide, Australia, 5000
Sponsors and Collaborators
S*BIO
Investigators
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
  More Information

No publications provided

Responsible Party: S*BIO
ClinicalTrials.gov Identifier: NCT00745550     History of Changes
Other Study ID Numbers: SB1518-2008-003
Study First Received: September 2, 2008
Last Updated: April 19, 2012
Health Authority: Australia: Human Research Ethics Committee
United States: Food and Drug Administration

Keywords provided by S*BIO:
SB1518
Chronic Idiopathic Myelofibrosis
Myeloproliferative disorders
 Polycythemia Vera
Essential Thrombocythemia
JAK2 inhibitor

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Thrombocytosis
 Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on May 23, 2013