SCIO-469: Open-Label Study for Patients With Myelodysplastic Syndromes.

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 expression and activity of cytokines that play a role in the progression of MDS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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