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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05209295

Studienbeginn:
Mai 2024

Letztes Update:
10.04.2024

Wirkstoff:
Onureg

Indikation (Clinical Trials):
Neoplasms, Hepatic Insufficiency, Liver Failure

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect Contact Center www.BMSStudyConnect.com
Kontakt:
Phone: 855-907-3286
E-Mail: Clinical.Trials@bms.com» Kontaktdaten anzeigen
First line of the email MUST contain the NCT# and the Site #.

Studienlocations
(3 von 22)

Tulane Cancer Center
70112 New Orleans
United StatesZurückgezogen» Google-Maps
Local Institution - 0007
11776 Port Jefferson Station
United StatesZurückgezogen» Google-Maps
Local Institution - 9000
54622 Thessaloniki
GreeceZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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)

2. AUC0-∞: Estimation of AUC calculated from time zero to infinity (Time Frame - Day 1)

3. Cmax: Observed maximum concentration (Time Frame - Day 1)

Secondary outcome:

1. Incidence of adverse events (Time Frame - Up to 9 Months)

2. Incidence of serious adverse events (Time Frame - Up to 9 Months)

3. Number of participants with clinically significant changes in electrocardiogram parameters (Time Frame - Up to 9 Months)

4. Incidence of clinically significant changes in vital signs: Body temperature (Time Frame - Up to 9 Months)

5. Incidence of clinically significant changes in vital signs: Respiratory rate (Time Frame - Up to 9 Months)

6. Incidence of clinically significant changes in vital signs: Blood pressure (Time Frame - Up to 9 Months)

7. Incidence of clinically significant changes in vital signs: Heart rate (Time Frame - Up to 9 Months)

8. Incidence of clinically significant changes in clinical laboratory results: Hematology tests (Time Frame - Up to 9 Months)

9. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests (Time Frame - Up to 9 Months)

10. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests (Time Frame - Up to 9 Months)

11. Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status (Time Frame - Up to 9 Months)

12. Incidence of clinically significant changes in clinical laboratory results: Liver Function tests (Time Frame - Up to 9 Months)

13. Number of clinically significant changes in physical examinations (Time Frame - Up to 9 Months)

14. Number of participants with a recording of concomitant medications (Time Frame - Up to 9 Months)

15. Number of participants with a recording of concomitant procedures (Time Frame - Up to 9 Months)

Studien-Arme

  • Experimental: Group 1
  • Experimental: Group 2
  • Other: Group 3
    Control - participants with normal hepatic function

Geprüfte Regime

  • Onureg (CC-486, Oral Azacitidine):
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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