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

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

Official Title
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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

Conditions
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Myelodysplastic Syndrome

Intervention / Treatment
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* Drug: CC-1088


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 400 mg CC-1088<br> | Drug: CC-1088<br>* 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)<br>|
| Experimental: 800 mg CC-1088<br> | Drug: CC-1088<br>* 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)<br>|
| Experimental: 1200 mg CC-1088<br> | Drug: CC-1088<br>* 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)<br>|
| Experimental: 1500 mg CC-1088<br> | Drug: CC-1088<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myelodysplastic syndrome