NCT00045786

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2002

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

September 9, 2002

Last Update Submit

April 24, 2017

Conditions

Myelodysplastic Syndrome

Keywords

myelodysplastic syndrome

Study Arms (4)

400 mg CC-1088

EXPERIMENTAL
Drug: CC-1088

800 mg CC-1088

EXPERIMENTAL
Drug: CC-1088

1200 mg CC-1088

EXPERIMENTAL
Drug: CC-1088

1500 mg CC-1088

EXPERIMENTAL
Drug: CC-1088

Interventions

CC-1088DRUG

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)

1200 mg CC-10881500 mg CC-1088400 mg CC-1088800 mg CC-1088

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush-Presbyterian-St Luke's Medical Center

Chicago, Illinois, 60612-3515, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Robert Knight

    Celgene Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2002

First Posted

September 11, 2002

Study Start

October 1, 2001

Primary Completion

December 1, 2001

Study Completion

November 1, 2003

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

US(1)