A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED PHASE III STUDY OF IPATASERTIB IN COMBINATION WITH PACLITAXEL AS A TREATMENT FOR PATIENTS WITH PIK3CA/AKT1/PTEN-ALTERED, LOCALLY ADVANCED OR METASTATIC, TRIPLE-NEGATIVE BREAST CANCER OR HORMONE RECEPTOR–POSITIVE, HER2-NEGATIVE BREAST CANCER

F. Hoffmann- La Roche, Ltd /Genentech Inc,0 个研究点目标入组 38 人开始时间: 2017年10月17日最近更新: 2023年9月4日

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•be ≥ 18 years of age on the day of signing informed consent. require treatment with IV antibiotic therapy for hospital-acquired bacterial pneumonia
•(HABP) or ventilator-associated bacterial pneumonia (VABP). fulfill the clinical and radiographic criteria. have an adequate baseline lower respiratory tract specimen obtained for Gram stain and culture. have an infection known or thought to be, in the opinion of the investigator, caused by microorganisms susceptible to the IV study therapy. agree to allow any bacterial isolates. understand (or have a legal representative that understands) the study procedures,
•alternative treatments available, and risks involved with the study, and voluntarily
•agree to participate by giving written informed consent for the trial. The subject is a male who is not of reproductive potential.the subject is a female who is not of reproductive potential.the subject is a female or a male who is of reproductive potential and agrees to
•avoid becoming pregnant or impregnating a partner.

•has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only. has confirmed or suspected community-acquired bacterial pneumonia. has confirmed or suspected pneumonia of viral, fungal, or parasitic etiology. has HABP/VABP caused by an obstructive process. has a carcinoid tumor or carcinoid syndrome. has active immunosuppression. is expected to survive < 72 hours. has a concurrent condition or infection that, in the investigator’s judgment, would preclude evaluation of therapeutic response. has received effective antibacterial drug therapy for the index infection of HABP/VABP for a continuous duration of more than 24 hours during the previous 72 hours. has a history of serious allergy, hypersensitivity or any serious reaction to any of the following: any penicillin and β-lactamase. is a female who is pregnant or is expecting to conceive, is breastfeeding, or plans to breastfeed prior to completion of the study. has a history of a seizure disorder. is anticipated to be treated with any of the following medications during the course of
•study therapy: valproic acid or divalproex, others. has an estimated or actual creatinine clearance of < 15 mL/min at screening. Please refers to the protocol for more information.

发起方

F. Hoffmann- La Roche, Ltd /Genentech Inc,