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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT00045786
First received: September 9, 2002
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).

Condition Intervention Phase
Myelodysplastic Syndrome
Drug: CC-1088
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Celgene:

Enrollment: 18
Study Start Date: October 2001
Study Completion Date: November 2003
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045786

Locations
United States, Illinois
Rush-Presbyterian-St Luke's Medical Center
Chicago, Illinois, United States, 60612-3515
Sponsors and Collaborators
Celgene
Investigators
Study Director: Robert Knight Celgene Corporation
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00045786     History of Changes
Other Study ID Numbers: CC-1088-MDS-801-001
Study First Received: September 9, 2002
Last Updated: April 24, 2017

Keywords provided by Celgene:
myelodysplastic syndrome

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on May 25, 2017