Deutsches Leukämie-Studienregister
Studie: 64619178EDI1001

Kurzübersicht
Öffentlicher Titel Phase I first-in-human Studie zum PRMT5-Hemmer JNJ-64619178 bei fortgeschrittenen Krebserkrankungen
Wissenschaftl. Titel A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Subjects With Advanced Cancers
Kurztitel 64619178EDI1001
Studiennummer KN/ELN LN_NN_2020_705
Studiengruppe NN
Studienart multizentrisch, einarmig, prospektiv, offen
Studienphase Phase I
Erkrankung Myelodysplastisches Syndrom (MDS) - Niedrigrisko und Intermediär I
Leukämiestadium .
Einschlusskriterien
  • B cell non-Hodgkin lymphoma (NHL) or solid tumors, or lower risk MDS
  • At least 1 measurable site of disease for B cell-NHL and solid tumors
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Adequate organ function
  • Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and prior to the first dose of study drug. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after receiving the last dose of study drug
Ausschlusskriterien
  • History of, or known, central nervous system (CNS) involvement
  • Prior solid organ transplantation
  • Either of the following: a) Received an autologous stem cell transplant less than or equal (<=) 9 months before the first dose of study drug B) Prior treatment with allogenic stem cell transplant
  • History of malignancy (other than the disease under study) within 3 years before the first administration of study drug. Exceptions include squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
  • Known allergies, hypersensitivity, or intolerance to JNJ-64619178 or its excipient
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 08.10.2020
Kurzprotokoll Kurzprotokoll
Sponsoren Janssen
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT03573310 (primäres Register)
European Clinical Trials Database - EUDRACT 2018-000067-87
erstellt 19.11.2020 Zenawit Krüger
geändert 30.12.2020 Student Studienregister
© Informationszentrum im Kompetenznetz Leukämien | Ohne Gewähr für Richtigkeit oder Vollständigkeit | www.kompetenznetz-leukaemie.de | info@kompetenznetz-leukaemie.de