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

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT00045786
Collaborator
(none)
18
Enrollment
1
Location
4
Arms
25
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2001
Actual Primary Completion Date :
Dec 1, 2001
Actual Study Completion Date :
Nov 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: 400 mg CC-1088

Drug: 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)
Experimental: 800 mg CC-1088

Drug: 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)
Experimental: 1200 mg CC-1088

Drug: 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)
Experimental: 1500 mg CC-1088

Drug: 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)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rush-Presbyterian-St Luke's Medical Center Chicago Illinois United States 60612-3515

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Robert Knight, Celgene Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT00045786
    Other Study ID Numbers:
    • CC-1088-MDS-801-001
    First Posted:
    Sep 11, 2002
    Last Update Posted:
    Apr 25, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Celgene
    myelodysplastic syndrome
    Additional relevant MeSH terms:
    Preleukemia
    Myelodysplastic Syndromes
    Syndrome

    Study Results

    No Results Posted as of Apr 25, 2017