Status:
COMPLETED
A Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to to determine the recommended dose level of JNJ-30979754 (decitabine) as well as to assess the safety and effectiveness in patients with Myelodysplastic Syndrome (MDS).
Detailed Description
This is an open-label (both physician and patient know the name and dosage of drug), multi-center study. This study consists of two parts, Phase I and Phase II. In Phase I, approximately 9 participant...
Eligibility Criteria
Inclusion
- Myelodysplastic syndrome (de novo or secondary) fitting any of the recognized French-American-British classifications: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia with white blood cells less than 13,000 /mm3
- International Prognostic Scoring System (IPSS) greater than or equal to 0.5 (Intermediate-1, Intermediate-2 or high risk) by bone marrow assessment and bone marrow cytogenetics within 28 days before study registration
- 20 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Normal renal and hepatic function
Exclusion
- Acute Myeloid Leukemia (AML) with bone marrow blasts greater than or equal to 30%
- Participants with a history of high-dose cytarabine (Ara-C) therapy (greater than 1,000 mg/m2/day)
- Participants administered adrenal cortex hormones or anabolic hormones within 7 days of study initiation
- Participants who have received a colony stimulating factor (CSF) formulation within 7 days of study initiation
- Active double cancer
- Uncontrolled cardiac disease or cognitive heart failure
- Uncontrolled restrictive or obstructive pulmonary disease
- Uncontrolled diabetes mellitus
- Active viral or bacterial infection
- Known positive serology for Human immunodeficiency virus
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00796003
Start Date
July 1 2008
End Date
October 1 2010
Last Update
December 9 2013
Active Locations (7)
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1
Fukuoka, Japan
2
Hamamatsu, Japan
3
Hidaka, Japan
4
Nagasaki, Japan