Clinical trial NCT01011283: To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
Official title: A Randomized, Open-label, Parallel-Group Study Comparing the Efficacy and Safety of DACOGEN (Decitabine) for Injection and VIDAZA (Azacitidine) for Injection In Subjects With Intermediate or High Risk Myelodysplastic Syndromes (MDS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Myelodysplastic Syndromes
Keywords: MDS
Myelodysplastic Syndromes
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.


Eligibility criteria: Inclusion Criteria

Subjects who meet all of the following criteria may be included in the study:

1. Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1 transfusion dependent, Intermediate-2, or High-risk \[defined by International Prognostic Scoring System (IPSS) score of ≥0.5\] and recognized French-American-British (FAB) classifications
2. Male or female, 18 years of age or older with signed informed consent
3. Adequate renal function
4. Demonstrated normal liver function
5. Female subjects of childbearing age must have negative pregnancy test within 1 week of study entry and agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.
6. Male subjects must agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in the study:

1. Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering study (permitted if \> 2 weeks from study entry and if recovered from toxic effects of therapy)
2. Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing signs or symptoms of infection and without improvement despite appropriate treatment)
3. Pregnancy or current lactation
4. Significant concurrent disease, illness, or psychiatric disorder
5. Treatment with an investigational agent 30 days prior to the first dose of decitabine or azacitidine

Primary outcomes:
measure: Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.
timeFrame: 13 Weeks
Secondary outcomes:
measure: Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.
timeFrame: 36 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates
state: Alabama
city: Stanford
country: United States
facility: Stanford University Cancer Center
state: California
city: Stockton
country: United States
facility: Stockton Hematology Oncology
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: New Port Richey
country: United States
facility: Pasco Pinellas Cancer Center
state: Florida
city: St. Petersburg
country: United States
facility: Gulf Coast Oncology
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Sioux City
country: United States
facility: Siouxland Haeatology - Oncology Associates
state: Iowa
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Great Falls
country: United States
facility: Sletten Cancer Institute
state: Montana
city: New York
country: United States
facility: Cornell Medical Center
state: New York
city: Concord
country: United States
facility: Carolinas Medical Center NorthEast NorthEast Oncology Associates
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: Oncology and Hematology Care
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: La Crosse
country: United States
facility: Gunderson Clinic Ltd.
state: Wisconsin
Study officials:
affiliation: Eisai Inc.
name: Karen Stein
role: STUDY_DIRECTOR
References: