Pharmacokinetic Trial of Decitabine (Dacogen) Administere... | NCT01378416

NCT01378416

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: Decitabine (Dacogen)

Name	Type	Description	Arm Group Labels	Other Names
Decitabine (Dacogen)	Drug	Intravenous injection; total dose-per-cycle was 135 mg/m^2 of decitabine.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average Total Body Clearance (Calculated From Rate and Concentration)	3-hour IV infusion, every 8 hours for three consecutive days. Average Total Body Clearance was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).	Day 1, Day 2, Day 3
Cmax (Maximum Plasma Concentration)	3-hour IV infusion, every 8 hours for three consecutive days. Cmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).	Day 1, Day 2, Day 3
Tmax (Time at Which Cmax First Observed)	3-hour IV infusion, every 8 hours for three consecutive days. Tmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).	Day 1, Day 2, Day 3
AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity	3-hour IV infusion, every 8 hours for three consecutive days. AUC (0-∞) was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).	Day 1, Day 2, day 3

Secondary Outcomes

Measure	Description	Time Frame
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)	Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients	6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Each patient had to meet the following criteria to be eligible for the study:

Patients with MDS (de novo or secondary) must have been 60 years or older and have had disease fitting any of the recognized French-American-British classifications OR chronic myelomonocytic leukemia (with white blood cell [WBC] <12,000/μL) AND have had an International Prognostic Scoring System score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of study entry.
Patients with AML (≥30% bone marrow blasts) must have been age 18 years or older and had previously received standard induction chemotherapy and/or had failed approved therapies.
Must have had Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Must have signed an Institutional Review Board (IRB)-approved informed consent form, indicating his/her awareness of the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
Must have had adequate renal and hepatic function (creatinine ≤2.0 mg/dL, total bilirubin <2.0 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3.0 X institutional upper limit of normal).
Must have had life expectancy of at least 12 weeks.
Must have recovered from all toxic effects of all prior therapy before entry into this study.

Exclusion Criteria:

Patients with MDS must not have been candidates for high-dose chemotherapy, bone marrow or stem cell transplant.
Must not have had acute promyelocytic leukemia (M3 classification).
Must not have received immunosuppressive therapy for 30 days prior to study entry.
Must not have had central nervous system (CNS) leukemia.
Must not have received systemic corticosteroids, interferon, interleukins or other hormonal therapy within 30 days prior to study entry. Use of corticosteroids (topical and inhaled corticosteroids) was permitted and prophylactic steroids may have been used to treat or prevent transfusion reactions.

Name	Affiliation	Role
Gerard Kennealey, MD	Eisai Medical Research (formerly MGI Pharma Inc.)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

ID	Title	Description
FG000	Decitabine	A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Decitabine	A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)

Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients

Posted

Number

Participants

6 weeks

ID	Title	Description
OG000	Decitabine	A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.

Units	Counts
Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Decitabine	A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.

ID	Term
D007938	Leukemia
D015470	Leukemia, Myeloid, Acute
D009190	Myelodysplastic Syndromes
D009369	Neoplasms

ID	Term
D009370	Neoplasms by Histologic Type
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007951	Leukemia, Myeloid

ID	Term
D001374	Azacitidine
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine