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

NCT00113893 | Completed Phase 2

• 1 other identifier: CR005179
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bone Marrow Diseases; Myelodysplastic Syndromes; Hematologic Diseases; Bone Marrow Neoplasms

Keywords

Myelodysplastic syndromes; p38 MAP kinase; Bone marrow diseases; SCIO-469

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Major or Minor Erythroid Response (Hematological Improvement - Erythroid [HI-E])

  Improvement in Erythroid (HI-E) lineage will be assessed as per International Working Group (IWG) criteria. HI-E major response is defined as greater than 2.0 gram per deciliter g/dL increase in hemoglobin for red blood cell (RBC) transfusion-dependent participants, transfusion independence. HI-E minor response is defined as 1.0 to 2.0 g/dL increase in hemoglobin for RBC transfusion-dependent participants and 50 percent decrease in transfusion requirements.

  Week 16

Secondary Outcomes (4)

• Percentage of Participants Achieving Major or Minor Neutrophil Response (HI-N)

  Week 16

• Percentage of Participants Achieving Major or Minor Platelet Response (HI-P)

  Week 16

• Percentage of Participants Achieving Complete or Partial Bone Marrow (BM) Response

  Week 16

• Percentage of Participants Achieving Major or Minor Cytogenetic Response

  Week 16

Study Arms (4)

Scio-469 30 Milligram (mg)

EXPERIMENTAL

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.

Drug: SCIO-469

Scio-469 60 mg

EXPERIMENTAL

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.

Drug: SCIO-469

Scio-469 90 mg

EXPERIMENTAL

SCIO-469 tablet will be administered orally at a dose of 90 mg thrice daily (270 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.

Drug: SCIO-469

Scio-469 120 mg

EXPERIMENTAL

SCIO-469 tablet will be administered orally at a dose of 120 mg thrice daily (360 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.

Drug: SCIO-469

Interventions

SCIO-469 DRUG

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.

Scio-469 30 Milligram (mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scios, Inc.: lead

MeSH Terms

Conditions

Bone Marrow Diseases; Myelodysplastic Syndromes; Hematologic Diseases; Bone Marrow Neoplasms

Interventions

SCIO-469

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2005
• First Posted: June 13, 2005
• Study Start: May 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 7, 2013

Record last verified: 2013-10