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

Myelofibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745550
• Other study ID #: SB1518-2008-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 2, 2008
• Last updated: April 19, 2012
• Start date: August 2008
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: S*BIO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Myelofibrosis
• Myeloproliferative Disorders
• Polycythemia
• Polycythemia Vera
• Primary Myelofibrosis
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Drug:
• SB1518
SB1518 taken orally daily for 28 consecutive days in a 28-day cycle

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Mayo Clinic	Scottsdale	Arizona
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
S*BIO

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily		Throughout the study	Yes
Primary	Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose		Throughout the study	Yes
Secondary	Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF		Throughout the study	Yes
Secondary	Assess the pharmacokinetic profile of SB1518		Throughout the study	No
Secondary	Assess the pharmacodynamic profile of SB1518		Throughout the study	No