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


Phase 1
20 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Janssen Pharmaceutical K.K. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Pharmaceutical K.K.

Authority:

Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Study ID:

CR015406

NCT ID:

NCT00796003

Start Date:

July 2008

Completion Date:

October 2010

Related Keywords:

  • Myelodysplastic Syndrome
  • Myelodysplastic syndrome
  • MDS
  • Decitabine
  • Myelodysplastic Syndromes
  • Preleukemia

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