Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes
- Registration Number
- NCT00045786
- Lead Sponsor
- Celgene
- Brief Summary
The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related.
- Age ≥ 18 at the time of signing informed consent
- Patient must be able to adhere to the study visit schedule and other protocol requirements.
- Patient must understand and voluntarily sign an informed consent document.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test.
- Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- Women must not be pregnant or lactating.
Exclusion Criteria
- Pregnant and lactating women and WCBP who are not using adequate contraception.
- Myelosclerosis (or myelofibrosis) occupying >30% of marrow space
- Patients with iron deficiency (e.g., absent bone marrow iron store). If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be 220% and serum femtin not less than 50 ng/mL.
- Patients with uncorrected Bl2 or folate deficiency.
- Patients with contributing causes of anemia such as autoimmune or heredity, hemolytic disorders, or GI blood loss.
- Patients with a history of malignancy, except basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
- Patients with clinically significant, symptomatic and unstable pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary system diseases unrelated to their underlying hematologic disorder.
- Life-threatening or active infection requiring parenteral antibiotic therapy or other serious concurrent illness.
- Patients who have a history of testing positive for Hepatitis B surface antigenemia,'Hepatitis C, or HIV.
- Inadequate organ hction: renal insufficiency [serum creatinine levels >1.5 x upper limit of normal (ULN)] or hepatic impairment (bilirubin 22 mg/dL or AST/ALT 22 x ULN).
- Patients may not have received another investigational study drug within 30 days of entry in the present study.
- Requirement for ongoing therapy with corticosteroids.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 400 mg CC-1088 CC-1088 - 1500 mg CC-1088 CC-1088 - 800 mg CC-1088 CC-1088 - 1200 mg CC-1088 CC-1088 -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rush-Presbyterian-St Luke's Medical Center
🇺🇸Chicago, Illinois, United States