search
Back to results

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

Primary Purpose

Hepatic Insufficiency, Neoplasms

Status
Not yet recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Onureg
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatic Insufficiency focused on measuring CC-486, Azacitidine, Hepatic Impairment, Onureg, Myeloid Malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented diagnosis of Myelodysplastic syndrome, Acute myeloid leukemia, Multiple myeloma, Non-Hodgkin's lymphoma, Hodgkin's lymphoma or metastatic or inoperable solid tumors
  • Life expectancy of ≥ 3 months
  • Stable renal function without dialysis for at least 2 months prior to investigational product administration
  • Has moderate or severe hepatic impairment as defined by National Cancer Institute Organ Dysfunction Working Group criteria

Exclusion Criteria:

  • Chemotherapy or radiotherapy within 4 weeks prior to the first day of investigational product administration
  • Persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2
  • Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study
  • History of inflammatory bowel disease, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the investigational product and/or predispose the participant to an increased risk of gastrointestinal toxicity

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • University of Iowa
  • Tulane Cancer Center
  • University of Massachusetts Chan Medical School
  • Henry Ford Hospital
  • Local Institution
  • Local Institution
  • Virginia Cancer Specialists
  • Local Institution - 0011
  • Local Institution - 0010
  • Local Institution - 0014
  • Local Institution - 0012
  • Local Institution - 0084
  • Local Institution - 0085
  • Local Institution - 0086
  • Local Institution - 0076
  • Local Institution - 0075
  • Local Institution - 0074
  • Local Institution - 9000
  • Local Institution - 0018
  • Local Institution - 0017
  • Local Institution - 0015
  • Local Institution - 0078

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Group 1

Group 2

Group 3

Arm Description

Control - participants with normal hepatic function

Outcomes

Primary Outcome Measures

AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point
AUC0-∞: Estimation of AUC calculated from time zero to infinity
Cmax: Observed maximum concentration

Secondary Outcome Measures

Incidence of adverse events
Incidence of serious adverse events
Number of participants with clinically significant changes in electrocardiogram parameters
Incidence of clinically significant changes in vital signs: Body temperature
Incidence of clinically significant changes in vital signs: Respiratory rate
Incidence of clinically significant changes in vital signs: Blood pressure
Incidence of clinically significant changes in vital signs: Heart rate
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status
Incidence of clinically significant changes in clinical laboratory results: Liver Function tests
Number of clinically significant changes in physical examinations
Number of participants with a recording of concomitant medications
Number of participants with a recording of concomitant procedures

Full Information

First Posted
January 13, 2022
Last Updated
October 18, 2023
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT05209295
Brief Title
A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies
Official Title
A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics of CC-486 (Onureg®) in Subjects With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Adult Subjects With Myeloid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Insufficiency, Neoplasms
Keywords
CC-486, Azacitidine, Hepatic Impairment, Onureg, Myeloid Malignancies

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Experimental
Arm Title
Group 3
Arm Type
Other
Arm Description
Control - participants with normal hepatic function
Intervention Type
Drug
Intervention Name(s)
Onureg
Other Intervention Name(s)
CC-486, Oral Azacitidine
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point
Time Frame
Day 1
Title
AUC0-∞: Estimation of AUC calculated from time zero to infinity
Time Frame
Day 1
Title
Cmax: Observed maximum concentration
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Up to 9 Months
Title
Incidence of serious adverse events
Time Frame
Up to 9 Months
Title
Number of participants with clinically significant changes in electrocardiogram parameters
Time Frame
Up to 9 Months
Title
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame
Up to 9 Months
Title
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame
Up to 9 Months
Title
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame
Up to 9 Months
Title
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame
Up to 9 Months
Title
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame
Up to 9 Months
Title
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame
Up to 9 Months
Title
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame
Up to 9 Months
Title
Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status
Time Frame
Up to 9 Months
Title
Incidence of clinically significant changes in clinical laboratory results: Liver Function tests
Time Frame
Up to 9 Months
Title
Number of clinically significant changes in physical examinations
Time Frame
Up to 9 Months
Title
Number of participants with a recording of concomitant medications
Time Frame
Up to 9 Months
Title
Number of participants with a recording of concomitant procedures
Time Frame
Up to 9 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of Myelodysplastic syndrome, Acute myeloid leukemia, Non-acute promyelocytic leukemia, Chronic myelomonocytic leukemia, Philadelphia-negative myeloproliferative neoplasms, Myelodysplastic syndrome Myeloproliferative neoplasms overlap, Accelerated phase and blast phase Myeloproliferative neoplasms, Blastic plasmacytoid dendritic cell neoplasm according to the World Health Organization (WHO) 2016 classification Life expectancy of ≥ 3 months Stable renal function without dialysis for at least 2 months prior to investigational product administration Has moderate or severe hepatic impairment as defined by National Cancer Institute Organ Dysfunction Working Group criteria Exclusion Criteria: Chemotherapy or radiotherapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first day of investigational product administration Persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2 Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study History of inflammatory bowel disease, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the investigational product and/or predispose the participant to an increased risk of gastrointestinal toxicity Other protocol-defined inclusion/exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and the Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grerk Sutamtewagul, Site 0083
Phone
319-356-4200
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Massachusetts Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Gerber, Site 0068
Phone
508-635-7093
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Mattour, Site 0069
Phone
313-433-1718
Facility Name
Local Institution
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0004
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Local Institution - 0011
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
1629
Country
Argentina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0010
City
ABB
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0014
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0012
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0084
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
111151
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0084
Facility Name
Local Institution - 0085
City
Bogotá
State/Province
Distrito Capital De Bogotá
ZIP/Postal Code
110131
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0085
Facility Name
Local Institution - 0086
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0086
Facility Name
Local Institution - 0076
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86156
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0076
Facility Name
Local Institution - 0075
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0075
Facility Name
Local Institution - 0074
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0074
Facility Name
Local Institution - 9000
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 9000
Facility Name
Local Institution - 0018
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0017
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0015
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0078
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0078

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

We'll reach out to this number within 24 hrs