Clinical trial · Interventional
SCIO-469: Open-Label Study for Patients With Myelodysplastic Syndromes.
A Randomized, MultiCenter, Open-Label, Modified Dose-Ascension, Parallel Study of the Safety, Tolerability, and Efficacy of Oral SCIO-469 in Patients With Myelodysplastic Syndromes
NCT00113893CI-TRIAL-00012595completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Diseases | — | UNRESOLVED | — |
| Bone Marrow Neoplasms | Bone Marrow Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hematologic Diseases | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCIO-469 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Scio-469 30 Milligram (mg)
- description
- SCIO-469 tablet will be administered orally at a dose of 30 mg thrice daily (90 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
- interventionNames
- Drug: SCIO-469
- type
- EXPERIMENTAL
- label
- Scio-469 60 mg
- description
- SCIO-469 tablet will be administered orally at a dose of 60 mg thrice daily (180 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
- interventionNames
- Drug: SCIO-469
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.