search
Back to results

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

Primary Purpose

Myelodysplastic Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CC-1088
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring myelodysplastic syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rush-Presbyterian-St Luke's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

400 mg CC-1088

800 mg CC-1088

1200 mg CC-1088

1500 mg CC-1088

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 9, 2002
Last Updated
April 24, 2017
Sponsor
Celgene
search

1. Study Identification

Unique Protocol Identification Number
NCT00045786
Brief Title
Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
myelodysplastic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400 mg CC-1088
Arm Type
Experimental
Arm Title
800 mg CC-1088
Arm Type
Experimental
Arm Title
1200 mg CC-1088
Arm Type
Experimental
Arm Title
1500 mg CC-1088
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-1088
Intervention Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knight
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Rush-Presbyterian-St Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3515
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs