- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00796003
A Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome
October 10, 2013 updated by: Janssen Pharmaceutical K.K.
A Phase I/II Clinical Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan
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Hamamatsu, Japan
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Hidaka, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Shinjuku, Japan
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Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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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.
Other Names:
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Experimental: 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
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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.
Other Names:
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Experimental: 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
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase II: Overall Remission Rate (ORR): Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria (2000)
Time Frame: Up to 1 years after the last participant enrolled
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IWG response criteria (2000) - CR: bone marrow evaluations show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes.
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Up to 1 years after the last participant enrolled
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Phase I and II: Number of Participants Who Experienced Adverse Events
Time Frame: Up to 1.5 years after the last participant enrolled
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Up to 1.5 years after the last participant enrolled
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax)
Time Frame: Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1
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Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1
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Phase I: Area Under the Plasma Concentration-time Curve (AUC)
Time Frame: Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1
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Area under the curve from time zero to extrapolated infinite time (AUC Infinity) and area under the curve from time zero to last quantifiable concentration (AUC Last).
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Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1
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Phase I: Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)
Time Frame: Up to 28 Days of treatment Cycle 1
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IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia; PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes; HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.
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Up to 28 Days of treatment Cycle 1
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Phase II: Median Time to Remission
Time Frame: Up to 1.5 years after the last participant enrolled
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Median time required for the participants to achieve remission (complete remission+partial remission).
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Up to 1.5 years after the last participant enrolled
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Phase II: Median Time to Improvement
Time Frame: Up to 1.5 years after the last participant enrolled
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Median time required for the participants to achieve overall improvement (complete remission+partial remission+hematologic improvement)
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Up to 1.5 years after the last participant enrolled
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Phase II: Median Duration of Remission
Time Frame: Up to 1.5 years after the last participant enrolled
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Median time duration for which participants achieved remission (complete remission+partial remission).
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Up to 1.5 years after the last participant enrolled
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Phase II: Median Duration of Overall Improvement
Time Frame: Up to 1.5 years after the last participant enrolled
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Median time duration for which participants achieved overall improvement (complete remission+partial remission+hematologic improvement).
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Up to 1.5 years after the last participant enrolled
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Phase II: Overall Improvement Rate: Number of Participants Who Achieved Complete Response (CR)+Partial Response (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)
Time Frame: Up to 1.5 years after the last participant enrolled
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IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes.
HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.
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Up to 1.5 years after the last participant enrolled
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Phase II: Number of Participants With Cytogenic Response - as Per International Working Group (IWG) Response Criteria 2000 (Major/Minor) and IWG 2006 (Complete/Partial)
Time Frame: Up to 1.5 years after the last participant enrolled
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IWG 2000 - Major: disappearance of cytogenetic abnormality; Minor: 50% or more reduction in abnormal metaphases.
IWG 2006 - Complete: disappearance of the chromosomal abnormality without appearance of new ones; Partial: At least 50% reduction of the chromosomal abnormality.
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Up to 1.5 years after the last participant enrolled
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
November 20, 2008
First Submitted That Met QC Criteria
November 21, 2008
First Posted (Estimate)
November 24, 2008
Study Record Updates
Last Update Posted (Estimate)
December 9, 2013
Last Update Submitted That Met QC Criteria
October 10, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR015406
- 30979754-JPN-MDS-101 (Other Identifier: Janssen Pharmaceutical K.K., Japan)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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