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Completed

NCT Number: NCT00796003

A 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).

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fukuoka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-30979754 15 mg/m2

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.

Other names: decitabine

JNJ-30979754 20 mg/m2

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.

Other names: decitabine

Primary outcomes

  1. 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

    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.

  2. Phase I and II: Number of Participants Who Experienced Adverse Events

    Time frame: Up to 1.5 years after the last participant enrolled

Secondary outcomes

  1. 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

  2. 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

    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).

  3. 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

    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.

  4. Phase II: Median Time to Remission

    Time frame: Up to 1.5 years after the last participant enrolled

    Median time required for the participants to achieve remission (complete remission+partial remission).

  5. Phase II: Median Time to Improvement

    Time frame: Up to 1.5 years after the last participant enrolled

    Median time required for the participants to achieve overall improvement (complete remission+partial remission+hematologic improvement)

  6. Phase II: Median Duration of Remission

    Time frame: Up to 1.5 years after the last participant enrolled

    Median time duration for which participants achieved remission (complete remission+partial remission).

  7. Phase II: Median Duration of Overall Improvement

    Time frame: Up to 1.5 years after the last participant enrolled

    Median time duration for which participants achieved overall improvement (complete remission+partial remission+hematologic improvement).

  8. 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

    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.

  9. 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

    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.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Official study title

A Phase I/II Clinical Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 24, 2008
Registry last updated
Dec 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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