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

Phase 1

Completed

• Conditions: Myelofibrosis; Myeloproliferative Disorders; Polycythemia Vera; Essential Thrombocythemia

• Registration Number: NCT00745550
• Lead Sponsor: S*BIO

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-19
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (6)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States