NCT00745550

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: S*BIO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelofibrosis
• Myeloproliferative Disorders
• Polycythemia Vera
• Essential Thrombocythemia

Interventions

Type	Name	Description
DRUG	SB1518	SB1518 taken orally daily for 28 consecutive days in a 28-day cycle

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2008-09-03
• Last updated: 2012-04-20

Locations

6 sites across 2 countries: United States, Australia