Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).

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

Details

• Lead Sponsor: Celgene; Celgene Corporation

Criteria

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.