A Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Azacitidine; Decitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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