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

NCT00745550 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2012-04-20

No results posted yet for this study

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

Interventions

DRUG

SB1518

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

Sponsors & Collaborators

  • S*BIO

    lead INDUSTRY

Principal Investigators

  • John Seymour, M.D. · Peter MacCallum Cancer Centre, Australia

  • Andrew Roberts, M.D. · Melbourne Health

  • Bik To, MD · Royal Adelaide Hospital

  • Rami Komrokji, MD · H. Lee Moffitt Cancer Center and Research Institute

  • Martha Wadleigh, MD · Dana-Farber Cancer Institute

  • Ruben Mesa, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00745550 on ClinicalTrials.gov