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

Myelodysplastic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045786
• Other study ID #: CC-1088-MDS-801-001
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2002
• Last updated: April 24, 2017
• Start date: October 2001
• Est. completion date: November 2003

Study information

• Verified date: April 2017
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2003
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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)

Locations

Country	Name	City	State
United States	Rush-Presbyterian-St Luke's Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States,