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

Sponsor

S*BIO (Industry)

Overall Status

Completed

CT.gov ID

NCT00745550

Collaborator

(none)

Enrollment

Locations

Duration (Months)

9.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Myelofibrosis Myeloproliferative Disorders Polycythemia Vera Essential Thrombocythemia	Drug: SB1518	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Outcome Measures

Primary Outcome Measures

Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily [Throughout the study]
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose [Throughout the study]

Secondary Outcome Measures

Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF [Throughout the study]
Assess the pharmacokinetic profile of SB1518 [Throughout the study]
Assess the pharmacodynamic profile of SB1518 [Throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
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
5	Royal Melbourne Hospital	Melbourne	Victoria	Australia	3050
6	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