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A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

NCT00719836 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2012-04-20

No results posted yet for this study

Summary

This 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 advanced myeloid malignancies; 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 chronic idiopathic myelofibrosis (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

  • Srdan Verstovsek, M.D, Ph.D · M.D. Anderson Cancer Center

  • H. Joachim Deeg, M.D · Fred Hutchinson Cancer Center

  • Olatoyosi M. Odenike, M.D. · The University of Chicago Hospitals

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

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 NCT00719836 on ClinicalTrials.gov