Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes
NCT ID: NCT00045786
Last Updated: 2017-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2001-10-31
2003-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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400 mg CC-1088
CC-1088
400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
800 mg CC-1088
CC-1088
400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
1200 mg CC-1088
CC-1088
400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
1500 mg CC-1088
CC-1088
400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
Interventions
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CC-1088
400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Knight
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Rush-Presbyterian-St Luke's Medical Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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CC-1088-MDS-801-001
Identifier Type: -
Identifier Source: org_study_id
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