A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies
Phase 1
Completed
- Conditions
- Acute Myelogenous LeukemiaChronic Myelogenous LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic SyndromesMyelofibrosis
- Registration Number
- NCT00719836
- Lead Sponsor
- S*BIO
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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 in subjects with advanced myeloid malignancies 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 safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies Throughout the study Assess the pharmacokinetic and pharmacodynamic profile of SB1518 Throughout the study
Trial Locations
- Locations (3)
The University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States