Trials / Completed
CompletedNCT00719836
A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- S*BIO · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Acute Myelogenous Leukemia
- Chronic Myelogenous Leukemia
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndromes
- Myelofibrosis
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
- 2008-07-22
- Last updated
- 2012-04-20
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00719836. Inclusion in this directory is not an endorsement.