Status:
COMPLETED
Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.
Lead Sponsor:
Celgene
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical experience study is to determine whether CC-5013 is safe and effective (to include studying the process by which a drug is absorbed, distributed, metabolized, and eliminat...
Eligibility Criteria
Inclusion
- Must understand and voluntarily sign an informed consent form.
- Age ≥ 20 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low- or intermediate-1-risk disease associated with a deletion 5(q31-33) abnormality
- Symptomatic anemia secondary to MDS defined as:Untransfused Hb level \< 10.0 g/dL and a Functional Assessment of Cancer Therapy (FACT)-anemia subscale score of ≤ 74 or Transfusion dependent anemia
Exclusion
- Pregnant or lactating females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Prior therapy with lenalidomide.
- Patients with any of the following laboratory abnormalities within 14 days of starting study drug: Absolute Neutrophil Count (ANC) \< 750 cells/μL (0.75 x 10\^9/L) Platelet count \< 50,000/μL (50x10\^9/L) Serum creatinine \> 2.5 mg/dL Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3.0 x Upper Limit of Normal (ULN)
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00812968
Start Date
September 1 2007
End Date
September 1 2010
Last Update
November 19 2019
Active Locations (6)
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1
Celgene Clinical Site
Shimono, Tochigi, Japan, 329-0498
2
Celgene Clinical Site
Shibuya-ku, Tokyo, Japan, 150-8935
3
Celgene Clinical Site
Hiroshima, Japan, 734-8551
4
Celgene Clinical Site
Kyoto, Japan, 601-1495