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Sponsored by: |
Janssen Pharmaceutical K.K. |
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Information provided by: | Janssen Pharmaceutical K.K. |
ClinicalTrials.gov Identifier: | NCT00796003 |
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 |
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Myelodysplastic Syndrome |
Drug: Decitabine |
Phase I Phase II |
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 |
Estimated Enrollment: | 32 |
Study Start Date: | July 2008 |
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
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Japan | |
Recruiting | |
Tokyo, Japan, 104-0045 | |
Recruiting | |
Nagoya, Japan, 464-8681 | |
Recruiting | |
Nagoya N/A, Japan, 466-0814 |
Study Director: | Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. |
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 |
Decitabine MDS Myelodysplastic syndrome |
Myelodysplastic syndromes Preleukemia Precancerous Conditions Hematologic Diseases |
Myelodysplasia Myelodysplastic Syndromes Decitabine Bone Marrow Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Syndrome Enzyme Inhibitors Pharmacologic Actions |