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

Celgene

Status and phase: Completed; Phase 2

Conditions: Myelodysplastic Syndrome

Treatments: Drug: CC-1088

Study type: Interventional

Funder types: Industry

Identifiers

NCT00045786

CC-1088-MDS-801-001

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 4 patient groups

400 mg CC-1088

Experimental group

Treatment:

Drug: CC-1088

800 mg CC-1088

Experimental group

Treatment:

Drug: CC-1088

1200 mg CC-1088

Experimental group

Treatment:

Drug: CC-1088

1500 mg CC-1088

Experimental group

Treatment:

Drug: CC-1088