Phase 1
N=39
A Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome
Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00796003 ↗Enrolled (actual)
39
Serious AEs
30.2%
Results posted
Dec 2013
Primary outcome: Primary: 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) — 7; 2 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- JNJ-30979754 15 mg/m2 (Drug); JNJ-30979754 20 mg/m2 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
7; 2 | <0.0001 sig |
| PRIMARY Phase I and II: Number of Participants Who Experienced Adverse Events |
3; 6; 34 | — |
| SECONDARY Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax) |
151.7; 166.4; 142.0; 190.6 | — |
| SECONDARY Phase I: Area Under the Plasma Concentration-time Curve (AUC) |
149.0; 155.2; 136.0; 152.0; 150.0; 156.1 | — |
| SECONDARY 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) |
1; 1; 1; 2 | — |
| SECONDARY Phase II: Median Time to Remission |
130.0 | — |
| SECONDARY Phase II: Median Time to Improvement |
26.5 | — |
| SECONDARY Phase II: Median Duration of Remission |
489 | — |
| SECONDARY Phase II: Median Duration of Overall Improvement |
532 | — |
| SECONDARY 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) |
7; 2; 5 | — |
| SECONDARY Phase II: Number of Participants With Cytogenic Response - as Per International Working Group (IWG) Response Criteria 2000 (Major/Minor) and IWG 2006 (Complete/Partial) |
6; 1; 10; 3 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00796003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.