Clinical trial NCT00045786: Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes
Official title: A Multi-center, An Open Label, Dose-Escalation Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment for Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndrome
Keywords: myelodysplastic syndrome
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2002-09-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush-Presbyterian-St Luke's Medical Center
state: Illinois
Study officials:
affiliation: Celgene Corporation
name: Robert Knight
role: STUDY_DIRECTOR
References: