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A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia
Bu çalışma, akut miyelojenöz lösemi (acute myelogenous leukemia, AML) olan kişilerde RO5503781 adlı ilacı tek başına ya da Cytarabine ile birlikte incelemektedir. Çalışmaya, akut promiyelositik lösemi dışında AML tanısı doğrulanmış, karaciğer ve böbrek fonksiyonları yeterli olan hastalar alınmıştır. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Documented/confirmed acute myelogenous leukemia (AML), except for acute promyelocytic leukemia * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 in Part 1 and Part 2, participants enrolled in the extension/tail portion, Part 3 and Part 4 must have an ECOG performance status of 0 or 1 * All non-hematological adverse events of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade less than or equal to (\</=) 2 prior to starting therapy * Adequate hepatic and renal function * Willing to submit the blood sampling and bone marrow sampling required by protocol Additional inclusion criteria for Parts 1-4 may apply. Exclusion Criteria: * Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea as defined in protocol * History of allergic or toxic reactions attributed to cytarabine (Part 2) or history of allergic reactions to components of the formulated product * Current evidence of central nervous system (CNS) leukemia * Participants with severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * Participants with evidence of electrolyte imbalance greater than or equal to (\>/=) Grade 2 which cannot be corrected prior to study initiation * Pregnant or breastfeeding women * Human immunodeficiency virus (HIV) - positive participants receiving anti-retroviral therapy * Participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products Additional exclusion criteria for Parts 1-4 may apply.