A Clinical Pharmacology and Exploratory Study of Decitabine Injection in Myelodysplastic Syndrome. - Full Text View

Sponsored by:	Janssen Pharmaceutical K.K.
Information provided by:	Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:	NCT00796003

Purpose

The objectives of this study are: Phase 1 part: To assess the safety and the recommended dose of decitabine, Phase 2 part: To assess the efficacy and safety of the recommended dose of decitabine confirmed in the phase I part.

Condition	Intervention	Phase
Myelodysplastic Syndrome	Drug: Decitabine	Phase I Phase II

Drug Information available for: 5-Aza-2'-deoxycytidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Clinical Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome

Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:

To assess the safety and recommended dose in phase 1 part. To assess the efficacy by remission rate (complete remission + partial remission) in phase 2 part.

Secondary Outcome Measures:

Time to remission, duration of remission, time to progression to Acute Myeloid Leukemia (AML) or death, therapeutic response (complete remission + partial remission + hematologic improvement), transfusion frequency, cytogenetic response

Estimated Enrollment:	32
Study Start Date:	July 2008

Detailed Description:

This is a phase 1/2, open-label (both physician and patient know the name and dosage of drug), multi-center trial in Myelodysplastic Syndrome (MDS). The purpose of this study is to assess the safety and efficacy of decitabine as well as to determine the recommended dose in patients with MDS. This trial consists of two parts, phase 1 part and phase 2 part. Phase 1 part: The objectives of phase 1 part are to assess the safety of decitabine and to determine the recommended dose for MDS. The dosage is 15mg/m2/day or 20mg/m2/day by 1-hour IV infusion for 5 consecutive days. Primary measures of this phase 1 part include adverse events. In patients enrolled in the phase I part, pharmacokinetics and pharmacodynamics of decitabine will also be analyzed. Phase 2 part: The objectives of phase 2 part are to assess the efficacy and safety of decitabine. The initial dose (dose level 1) is set at 15 mg/m2/day. When the dose of 20 mg/m2/day (dose level 2) is confirmed to be well tolerated in the phase 1 part, patients will be added to the dose level 2 group until a total number of 26 patients to evaluate the efficacy and safety of decitabine in the phase 2 part. The primary efficacy endpoint is remission rate (complete remission + partial remission) at the end of study.

One hour intravenous infusion (using an infusion pump) for 5 consecutive days

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

MDS (de novo or secondary) fitting any of the recognized French-American-British (FAB) classifications: refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), chronic myelomonocytic leukemia (CMML) with WBC <13,000 /mm3
International Prognostic Scoring System (IPSS) >= 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 (creatinine <= 2 mg/dL, bilirubin <= 1.5 mg/dL, SGOT and SGPT <= 2 times the upper limit of normal range, SaO2 >= 90% (room air), without ECG abnormality)
Written informed consent

Exclusion Criteria:

Acute Myeloid Leukemia (AML) with bone marrow blasts >=30%
Patients with a history of high-dose cytarabine (Ara-C) therapy (>1,000 mg/m2/day)
Patients administered adrenal cortex hormones or anabolic hormones within 7 days of study initiation
Patients 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 HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796003

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

info1@veritasmedicine.com

Locations

Japan
	Recruiting
Tokyo, Japan, 104-0045
	Recruiting
Nagoya, Japan, 464-8681
	Recruiting
Nagoya N/A, Japan, 466-0814

Sponsors and Collaborators

Janssen Pharmaceutical K.K.

Investigators

Study Director:

Janssen Pharmaceutical K.K. Clinical Trial

Janssen Pharmaceutical K.K.

More Information

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR015406
Study First Received:	November 20, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00796003
Health Authority:	Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by Janssen Pharmaceutical K.K.:

Decitabine
MDS
Myelodysplastic syndrome

Study placed in the following topic categories:

Myelodysplastic syndromes
Preleukemia
Precancerous Conditions
Hematologic Diseases

Myelodysplasia
Myelodysplastic Syndromes
Decitabine
Bone Marrow Diseases

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Syndrome
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009