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

NCT00796003 | Completed Phase 1 Results DMC

• 2 other identifiers: CR01540630979754-JPN-MDS-101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 7

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).

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic syndrome; MDS; Decitabine; JNJ-30979754

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Up to 1 years after the last participant enrolled

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

  Up to 1.5 years after the last participant enrolled

Secondary Outcomes (9)

• Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax)

  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

• Phase I: Area Under the Plasma Concentration-time Curve (AUC)

  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

• 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)

  Up to 28 Days of treatment Cycle 1

• Phase II: Median Time to Remission

  Up to 1.5 years after the last participant enrolled

• Phase II: Median Time to Improvement

  Up to 1.5 years after the last participant enrolled

Study Arms (3)

Phase I: JNJ-30979754 15 mg/m2

EXPERIMENTAL

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

Drug: JNJ-30979754 15 mg/m2

Phase I: JNJ-30979754 20 mg/m2

EXPERIMENTAL

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

Drug: JNJ-30979754 20 mg/m2

Phase II: JNJ-30979754 20 mg/m2

EXPERIMENTAL

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

Drug: JNJ-30979754 20 mg/m2

Interventions

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.

Also known as: decitabine

Phase I: JNJ-30979754 15 mg/m2

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.

Also known as: decitabine

Phase I: JNJ-30979754 20 mg/m2; Phase II: JNJ-30979754 20 mg/m2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Normal renal and hepatic function

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (7)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Hamamatsu, Japan

Location

Unknown Facility

Hidaka, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Shinjuku, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 22816487 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Director
• Organization: Janssen Pharm KK Japan

+81-3-4411-5801

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 9, 2013
• Results First Posted: December 9, 2013

Record last verified: 2013-10

Locations

JP (7)