Status:
COMPLETED
SCIO-469: Open-Label Study for Patients With Myelodysplastic Syndromes.
Lead Sponsor:
Scios, Inc.
Conditions:
Bone Marrow Diseases
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and effectiveness of oral SCIO-469 in patients with myelodysplastic syndromes. SCIO-469 belongs to a new class of treatments that inhibit expressio...
Detailed Description
SCIO-469 belongs to a new class of treatment that inhibits p38 MAP kinase. p38 MAPK activation controls the production of TNF-a, VEGF, and IL-1b. As an inhibitor of p38 MAPK, SCIO-469 blocks the synth...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of low/intermediate-1 MDS (for at least 12 weeks)
- Patients with anemia (average Hemoglobin \< 10 g/dL or \> or = to 4 units of Red Blood Cell counts in the last 8 weeks)
- Patients who have failed prior erythropoietin treatment
- Patients with an ECOG (Eastern Collaborative Oncology Group) score of 0, 1 or 2
Exclusion
- Patients with a International Prognostic Scoring System risk category high/intermediate-2
- Patients with treatment-related MDS associated with radiation, chemotherapy, and/or autologous transplant
- Patients with myelosclerosis (or myelofibrosis) occupying \> 30 % marrow space
- Patients who have received decitabine (DacogenTM) for MDS
- Patients who have received lenalidomide (RevlimidTM), steroids, erythropoietin, hydroxyurea, or growth factors within 4 weeks before study drug administration
- Patients who have received thalidomide within 8 weeks before study drug administration
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00113893
Start Date
May 1 2005
End Date
December 1 2007
Last Update
November 7 2013
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