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

NCT ID: NCT00796003

Last Updated: 2013-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-10-31

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 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.

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic syndrome; MDS; Decitabine; JNJ-30979754

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I: JNJ-30979754 15 mg/m2

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

Group Type: EXPERIMENTAL

JNJ-30979754 15 mg/m2

Intervention Type: DRUG

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.

Phase I: JNJ-30979754 20 mg/m2

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

Group Type: EXPERIMENTAL

JNJ-30979754 20 mg/m2

Intervention Type: DRUG

Phase I: 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. Phase II: 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 until the decitabine was expected to be effective in participants.

Phase II: JNJ-30979754 20 mg/m2

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

Group Type: EXPERIMENTAL

JNJ-30979754 20 mg/m2

Intervention Type: DRUG

Phase I: 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. Phase II: 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 until the decitabine was expected to be effective in participants.

Interventions

JNJ-30979754 15 mg/m2

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.

Intervention Type: DRUG

JNJ-30979754 20 mg/m2

Phase I: 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. Phase II: 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 until the decitabine was expected to be effective in participants.

Intervention Type: DRUG

Other Intervention Names

decitabine; decitabine

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Fukuoka, , Japan

Hamamatsu, , Japan

Hidaka, , Japan

Nagasaki, , Japan

Nagoya, , Japan

Shinjuku, , Japan

Tokyo, , Japan

Countries

Japan

References

Oki Y, Kondo Y, Yamamoto K, Ogura M, Kasai M, Kobayashi Y, Watanabe T, Uike N, Ohyashiki K, Okamoto S, Ohnishi K, Tomita A, Miyazaki Y, Tohyama K, Mukai HY, Hotta T, Tomonaga M. Phase I/II study of decitabine in patients with myelodysplastic syndrome: a multi-center study in Japan. Cancer Sci. 2012 Oct;103(10):1839-47. doi: 10.1111/j.1349-7006.2012.02386.x. Epub 2012 Sep 14.

Reference Type: DERIVED

PMID: 22816487 (View on PubMed)

Other Identifiers

30979754-JPN-MDS-101

Identifier Type: OTHER

Identifier Source: secondary_id

CR015406

Identifier Type: -

Identifier Source: org_study_id