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

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-028-17
• Date of registration: 17/10/2017
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann- La Roche, Ltd /Genentech Inc,
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 07/02/2018
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=028-17
• Study type: Interventional
• Study design: A randomized, double-blind (with in-house blinding), activecontrolled,; parallel-group, multi-site, trial of imipenem/cilastatin/; relebactam (also known as MK-7655A; hereafter referred to as; IMI/REL) compared with piperacillin/tazobactam (PIP/TAZ) in; subjects with hospital-acquired bacterial pneumonia (HABP) or; ventilator-associated bacterial pneumonia (VABP).
• Phase: III

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, France, Germany, Italy, Japan, Korea South, Mexico, Philippines, Portugal, Romania, Russian Federation, Spain, Taiwan, United Kindgdom, United States

Contacts

• Name: Sandra Paez Viale
• Affiliation: ROCHE FARMA (PERU) S.A.

• Name: Lizeth Landa Perez
• Affiliation: ROCHE FARMA (PERU) S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
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.

Exclusion criteria:
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.


Age minimum:
Age maximum:
Gender: --

Health Condition(s) or Problem(s) studied

C50

-C50 Malignant neoplasm of breast
Malignant neoplasm of breast

J15

Malignant neoplasm of breast

Intervention(s)

1. IMI/REL: powder for injection ,500mg/250mg, each 6 hours, 14 days, IV, Treatment 1 (IMI/REL)
2. PIP/TAZ: powder for injection, 4500 mg (4000 mg PIP/500 mg TAZ), each 6 hours, 14 days, IV, Treatment 2 (PIP/TAZ)

Secondary ID(s)

2017-001548-36

Source(s) of Monetary Support

F. HOFFMANN LA ROCHE LTD / GENENTECH INC

Ethics review

Status: Approved
Approval date: 18/07/2017
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 22/08/2017
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 25/10/2017
Contact:

[e-mail]

Instituto Nacional de Enfermedades Neoplasicas

7106099-3001

[e-mail]

Status: Approved
Approval date: 27/08/2018
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 28/08/2018
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 02/10/2018
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Results

• Results available: Yes
• Date Completed: 23/09/2022