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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Myelodysplastic Syndrome

Treatments: Drug: JNJ-30979754 15 mg/m2; Drug: JNJ-30979754 20 mg/m2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796003

30979754-JPN-MDS-101 (Other Identifier)

CR015406

Details and patient eligibility

About

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).

Full 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 participants will be enrolled ie, 3 participants for dose level 1 (15 mg/m2 of JNJ-30979754) and 6 participants for dose level 2 (20 mg/m2 of JNJ-30979754). Once the tolerability of 20 mg/m2 is confirmed additional 30 participants will be included to receive 20 mg/m2 and approximate total participants in Phase II will be 36. This study will include screening period (within 14 days prior to the day of initial administration of Cycle 1) and dosing period (1 cycle consists of administration of study medication for first 5 consecutive days + rested for 23 days; ie, total 28 days). Cycles will be reapeated in participants in whom decitabine was expected to be effective. Safety evaluations will include assessment of adverse events, vital signs, body weight, clinical laboratory tests: hematology, blood biochemistry and urinalysis, cardiopulmonary function tests: ECG, chest X ray and oximeter analysis.

Enrollment: 39 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Phase I: JNJ-30979754 15 mg/m2

Experimental group

Description:

JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1

Treatment:

Drug: JNJ-30979754 15 mg/m2

Phase I: JNJ-30979754 20 mg/m2

Experimental group

Description:

JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1

Treatment:

Drug: JNJ-30979754 20 mg/m2

Phase II: JNJ-30979754 20 mg/m2

Experimental group

Description:

JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles

Treatment:

Drug: JNJ-30979754 20 mg/m2