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The purpose of this study is to evaluate three things. The first being whether azacitidine is absorbed in the body at the same rate or proportion for different concentrations. The second is to determine the effect renal impairment has or does not have on the absorption of azacitidine. The third is to determine if azacitidine is safe and well tolerated in patients with renal function impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacitidine 25 mg/m^2 | Experimental | Participants with normal renal function received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m^2 daily on Days 1-7 of each 28-day cycle. |
|
| Azacitidine 50 mg/m^2 | Experimental | Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m^2 daily on Days 1-7 of each 28-day cycle. |
|
| Azacitidine 75 mg/m^2 | Experimental | Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m^2 daily on Days 1-7 of each 28-day cycle. |
|
| Azacitidine 100 mg/m^2 | Experimental | Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m^2 daily on Days 1-7 of each 28-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azacitidine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose | Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule. | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point | Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule. | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity | The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine after a single dose, calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation: AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant. | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Maximum Plasma Concentration of Azacitidine (Cmax) | The maximum observed plasma concentration of azacitidine after a single dose on Day 1. | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Time to Maximum Plasma Concentration of Azacitidine (Tmax) | The time to first maximum observed plasma concentration of azacitidine after a single dose on Day 1. |
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Inclusion Criteria:
Diagnosis of one of the following:
Patients with a history of treated brain metastases should be clinically stable for greater than 4 weeks prior to signing the informed consent form and off glucocorticoid therapy for central nervous system (CNS) edema for at least 4 weeks
Be capable of giving informed consent
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Have a life expectancy ≥ 3 months
Have stable renal function for at least 2 months
Have average calculated creatinine clearance of:
Have organ and marrow function at the screening and pre-dose visits as defined below:
Have a 12-lead electrocardiogram (ECG) that is not clinically significant, as determined by the Investigator, at screening
Have serum bicarbonate:
Women of childbearing potential may participate, providing are not pregnant and agree to use at least 2 effective contraceptive methods throughout the study
Males with a female partner of childbearing potential must agree to use at least 2 effective contraceptive methods throughout the study and to avoid fathering a child for 6 months following the date of the last dose of study medication
Be a nonsmoker or must not have smoked for at least 30 days before the screening visit and agree to abstain from smoking during study participation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Backstrom, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutter East Bay Hospitals | Berkeley | California | 94704 | United States | ||
| Palm Springs Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30091166 | Background | Wehmeyer J, Zaiss M, Losem C, Schmitz S, Niemeier B, Harde J, Hannig CV, Harich HD, Muller J, Klausmann M, Tessen HW, Potthoff K. Impact of performance status and transfusion dependency on outcome of patients with myelodysplastic syndrome, acute myeloid leukemia and chronic myelomonocytic leukemia treated with azacitidine (PIAZA study). Eur J Haematol. 2018 Dec;101(6):766-773. doi: 10.1111/ejh.13160. Epub 2018 Oct 25. | |
| 30442503 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azacitidine 25 mg/m^2 | Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1. |
| FG001 | Azacitidine 50 mg/m^2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment Phase |
|
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| Severe RI: azacitidine 75 mg/m^2 |
| Experimental |
Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m^2 daily on Days 1-7 of each 28-day cycle. |
|
| Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Terminal Phase Half-life of Azacitidine (t½) | The terminal phase half-life of azacitidine after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant. | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Apparent Total Clearance of Azacitidine (CL/F) | The apparent total clearance of azacitidine after a single dose on Day 1, calculated as Dose/AUC0-inf. | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Apparent Volume of Distribution of Azacitidine (Vz/F) | The apparent volume of distribution of azacitidine after a single dose on Day 1, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz) | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine | The effect of renal impairment on azacitidine pharmacokinetics was analyzed by comparing PK parameters obtained on Days 1 and 5 from participants with severe renal impairment and those with normal renal function. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule. | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Time Point After Single and Multiple Doses of Azacitidine | The area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule for participants with normal renal function and for participants with severe renal impairment. | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinity After Single and Multiple Doses of Azacitidine | The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine, after a single dose (Day 1) and multiple doses (Day 5), calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation: AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant. | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Maximum Plasma Concentration of Azacitidine (Cmax) After Single and Multiple Doses of Azacitidine | The maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and for participants with severe renal impairment. | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine | The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment. | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Terminal Phase Half-life of Azacitidine (t½) After Single and Multiple Doses of Azacitidine | The terminal phase half-life of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant. | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine | The apparent total clearance of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated as Dose/AUC0-inf. | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Apparent Volume of Distribution of Azacitidine (Vz/F) After Single and Multiple Doses of Azacitidine | The apparent volume of distribution of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz). | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| Number of Participants With Adverse Events (AEs) | A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:
The Investigator assessed each AE for potential causal relationship between the event and study drug. The intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5). | Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months). |
| Hialeah |
| Florida |
| 33012 |
| United States |
| MCG Cancer Center | Augusta | Georgia | 30912 | United States |
| Joliet Oncology-Hematology Associates, Ltd. | Joliet | Illinois | 60435 | United States |
| University of Kentucky-Markey Cancer Center Clinical Research Organization | Lexington | Kentucky | 40536 | United States |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Mid Dakota Clinical P.C. - Cancer Treatment and Research Center | Bismarck | North Dakota | 58501 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| Pharma Resource | East Providence | Rhode Island | 02915 | United States |
| Cancer Therapy and Research Center | San Antonio | Texas | 78229 | United States |
| Background |
| Platzbecker U, Middeke JM, Sockel K, Herbst R, Wolf D, Baldus CD, Oelschlagel U, Mutherig A, Fransecky L, Noppeney R, Bug G, Gotze KS, Kramer A, Bochtler T, Stelljes M, Groth C, Schubert A, Mende M, Stolzel F, Borkmann C, Kubasch AS, von Bonin M, Serve H, Hanel M, Duhrsen U, Schetelig J, Rollig C, Kramer M, Ehninger G, Bornhauser M, Thiede C. Measurable residual disease-guided treatment with azacitidine to prevent haematological relapse in patients with myelodysplastic syndrome and acute myeloid leukaemia (RELAZA2): an open-label, multicentre, phase 2 trial. Lancet Oncol. 2018 Dec;19(12):1668-1679. doi: 10.1016/S1470-2045(18)30580-1. Epub 2018 Nov 12. |
| 31009835 | Background | Stevens B, Winters A, Gutman JA, Fullerton A, Hemenway G, Schatz D, Miltgen N, Wei Q, Abbasi T, Vali S, Singh NK, Drusbosky L, Cogle CR, Hammes A, Abbott D, Jordan CT, Smith C, Pollyea DA. Sequential azacitidine and lenalidomide for patients with relapsed and refractory acute myeloid leukemia: Clinical results and predictive modeling using computational analysis. Leuk Res. 2019 Jun;81:43-49. doi: 10.1016/j.leukres.2019.04.005. Epub 2019 Apr 13. |
| Background | Laille E, et al. A 2-Part Phase I Study in Patients with Solid or Hematologic Malignancies: Dose Proportionality of Subcutaneous (SC) Azacitidine (AZA) and Pharmacokinetics of SC AZA in Patients with Severe Renal Impairment . Presented at American Society of Hematology 2011, December 10-13, 2011, San Diego, CA. Abstract No. 3480. |
| 29282890 | Background | Du X, Lai YY, Xiao Z, Liu T, Hu Y, Sun A, Li X, Shen ZX, Jin J, Yu L, Laille E, Dong Q, Songer S, Beach CL. Efficacy, safety and pharmacokinetics of subcutaneous azacitidine in Chinese patients with higher risk myelodysplastic syndromes: Results from a multicenter, single-arm, open-label phase 2 study. Asia Pac J Clin Oncol. 2018 Jun;14(3):270-278. doi: 10.1111/ajco.12835. Epub 2017 Dec 28. |
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
| FG002 | Azacitidine 75 mg/m^2 | Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. |
| FG003 | Azacitidine 100 mg/m^2 | Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
| FG004 | Severe RI: Azacitidine 75 mg/m^2 | Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. |
| FG005 | Extension Phase: Normal RF | Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle. |
| FG006 | Extension Phase: Severe RI | Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle. |
| Received Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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|
| Extension Phase |
|
|
Safety population. The total number of participants in the study was 27; 18 continued treatment in the extension phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azacitidine 25 mg/m^2 | Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1. |
| BG001 | Azacitidine 50 mg/m^2 | Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1. |
| BG002 | Azacitidine 75 mg/m^2 | Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. |
| BG003 | Azacitidine 100 mg/m^2 | Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
| BG004 | Severe RI: Azacitidine 75 mg/m^2 | Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. |
| BG005 | Extension Phase: Normal RF | Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle. |
| BG006 | Extension Phase: Severe RI | Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Data provided for initial treatment phase groups only. | Number | participants |
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| Race/Ethnicity, Customized | Data provided for initial treatment phase groups only. | Number | participants |
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| Region of Enrollment | Data provided for initial treatment phase groups only. | Number | participants |
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| Gender of Extension Period Participants | Number | participants |
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| Race: Extension Phase | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status: Initial Treatment Phase | Scale used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = fully active, no restrictions; 1 = restricted but ambulatory and capable of light work; 2 = ambulatory and capable of self-care but unable to work. 3 = Capable of only limited self care, confined to bed or chair more than 50% of waking hours. 4 = Completely disabled. Cannot carry on any self care. Totally confined to bed or chair. 5 = Dead. | Number | participants |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status: Extension Phase | Number | participants |
| ||||||||||||||||
| Body Surface Area (BSA) | Mean | Standard Deviation | m^2 |
| |||||||||||||||
| Cancer Diagnosis: Initial Treatment Phase | MDS = myelodysplastic syndrome; MM = multiple myeloma; RA = refractory anemia; RAEB-T = refractory anemia with excess blasts in transformation; RARS = refractory anemia with ringed sideroblasts; CMML = chronic myelomonocytic leukemia. | Number | participants |
| |||||||||||||||
| Cancer Diagnosis: Extension Phase | Number | participants |
|
| 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose | Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule. | Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
|
|
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| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point | Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity | The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine after a single dose, calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation: AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Maximum Plasma Concentration of Azacitidine (Cmax) | The maximum observed plasma concentration of azacitidine after a single dose on Day 1. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
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| Primary | Time to Maximum Plasma Concentration of Azacitidine (Tmax) | The time to first maximum observed plasma concentration of azacitidine after a single dose on Day 1. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only. | Posted | Median | Full Range | hours | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Terminal Phase Half-life of Azacitidine (t½) | The terminal phase half-life of azacitidine after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Apparent Total Clearance of Azacitidine (CL/F) | The apparent total clearance of azacitidine after a single dose on Day 1, calculated as Dose/AUC0-inf. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters/hour | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Apparent Volume of Distribution of Azacitidine (Vz/F) | The apparent volume of distribution of azacitidine after a single dose on Day 1, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz) | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine | The effect of renal impairment on azacitidine pharmacokinetics was analyzed by comparing PK parameters obtained on Days 1 and 5 from participants with severe renal impairment and those with normal renal function. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Time Point After Single and Multiple Doses of Azacitidine | The area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule for participants with normal renal function and for participants with severe renal impairment. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity After Single and Multiple Doses of Azacitidine | The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine, after a single dose (Day 1) and multiple doses (Day 5), calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation: AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
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| Primary | Maximum Plasma Concentration of Azacitidine (Cmax) After Single and Multiple Doses of Azacitidine | The maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and for participants with severe renal impairment. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
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| Primary | Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine | The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days. | Posted | Median | Full Range | hours | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
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| Primary | Terminal Phase Half-life of Azacitidine (t½) After Single and Multiple Doses of Azacitidine | The terminal phase half-life of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
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| Primary | Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine | The apparent total clearance of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated as Dose/AUC0-inf. | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters/hour | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
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| Primary | Apparent Volume of Distribution of Azacitidine (Vz/F) After Single and Multiple Doses of Azacitidine | The apparent volume of distribution of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz). | Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose |
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| Primary | Number of Participants With Adverse Events (AEs) | A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:
The Investigator assessed each AE for potential causal relationship between the event and study drug. The intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5). | Safety population, all enrolled patients who received at least one dose of azacitidine and who had at least one post-treatment safety assessment. | Posted | Number | participants | Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months). |
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Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azacitidine 25 mg/m^2 | Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1. | 0 | 5 | 4 | 5 | ||
| EG001 | Azacitidine 50 mg/m^2 | Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1. | 0 | 5 | 3 | 5 | ||
| EG002 | Azacitidine 75 mg/m^2 | Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. | 4 | 6 | 5 | 6 | ||
| EG003 | Azacitidine 100 mg/m^2 | Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. | 1 | 5 | 5 | 5 | ||
| EG004 | Severe RI: Azacitidine 75 mg/m^2 | Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. | 1 | 6 | 6 | 6 | ||
| EG005 | Extension Phase: Normal RF | Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle. | 8 | 14 | 9 | 14 | ||
| EG006 | Extension Phase: Severe RI | Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle. | 3 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Hemoglobin decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hernia pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site vesicles | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Vaginal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Psychiatric symptom | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vulval disorder | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally thirty (30) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Adverse Event |
|
| No Longer Receiving Clinical Benefit |
|
| Physician Decision |
|
| Death |
|
| Extension Treatment Period |
|
| Male |
|
| White |
|
| Male |
|
| White |
|
| 1 |
|
| 2 |
|
| 1 |
|
| 2 |
|
| Extension Period |
|
| Myelodysplastic syndrome-RARS |
|
| Myelodysplastic syndrome-RAEB-T |
|
| Chronic myelomonocytic leukemia |
|
| Solid tumor |
|
| Multiple myeloma |
|
| Myelodysplastic syndrome-RARS |
|
| Myelodysplastic syndrome-RAEB-T |
|
| Chronic myelomonocytic leukemia |
|
| Solid tumor |
|
| Multiple myeloma |
|
| OG003 | Azacitidine 100 mg/m^2 | Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
|
|
|
| OG003 | Azacitidine 100 mg/m^2 | Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
|
|
|
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
|
|
|
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
|
|
| Azacitidine 100 mg/m^2 |
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
|
|
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
|
|
|
| OG003 |
| Azacitidine 100 mg/m^2 |
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
|
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|---|---|
| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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| Participants |
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Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1. |
| OG002 | Azacitidine 75 mg/m^2 | Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. |
| OG003 | Azacitidine 100 mg/m^2 | Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1. |
| OG004 | Severe RI: Azacitidine 75 mg/m^2 | Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5. |
| OG005 | Extension Phase: Normal RF | Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle. |
| OG006 | Extension Phase: Severe RI | Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle. |
|
|