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

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

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

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndrome
• Intervention / Treatment: Drug: CC-1088

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612-3515
      • Rush-Presbyterian-St Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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)

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Robert Knight, Celgene Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): December 1, 2001
• Study Completion (Actual): November 1, 2003

Study Registration Dates

• First Submitted: September 9, 2002
• First Submitted That Met QC Criteria: September 10, 2002
• First Posted (Estimate): September 11, 2002

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: myelodysplastic syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: CC-1088-MDS-801-001