Content Block Tag: NRG-GY008

‘NRG-GY008 Documentation’ of page ‘NRG-GY008’

Amendment 4 Summary: A link to documentation page for the most recent information on pre-treatment assessments has been added to Sec 4.1.1; Urine Protein does not need to be determined using dipstick; drug ordering and supply information has been updated and also includes information on lancets; a paragraph was added to Sec 15.3.2 to further define […]

Read More

‘NRG-GY008: A Phase II Evaluation of Copanlisib (BAY 80-6946) (IND #130822), A Selective Inhibitor of PI3KCA, in patients with Persistent or Recurrent Endometrial Carcinoma Harboring PIK3CA Hotspot Mutations’ of page ‘NRG-GY008’

Principal Investigator/Co-Principal Investigator Alessandro Santin, M.D./Michal Birrer, M.D., M.P.H. Primary Objectives To assess the activity of copanlisib (BAY 80-6946) in patients with persistent or recurrent endometrial carcinoma harboring PIK3CA hotspot mutations with the frequency of objective response. Patient Population Patients must have recurrent or persistent endometrial cancer (endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial […]

Read More