Phase II study of copanlisib (BAY 80-6946) in combination with gemcitabine and cisplatin in advanced cholangiocarcinoma

Phase II study of copanlisib (BAY 80-6946) in combination with gemcitabine and cisplatin in advanced cholangiocarcinoma

Study Name
  Phase II study of copanlisib (BAY 80-6946) in combination with gemcitabine and cisplatin in advanced cholangiocarcinoma
Study Center
Institution Name
  Moffitt Cancer Center
Institution Address
  12902 Magnolia Drive
City
  Tampa
State
  Florida
Zip Code
  33612
Study Contacts
Principal Investigator
  Richard Kim, MD
P.I. Phone
  (813) 745-1277
P.I. Email
  richard.kim@moffitt.org
Study Coordinator
  Fatima Tariq
Study Coordinator Phone
  (813) 745-1277
Study Coordinator Email
  fatima.tariq@moffitt.org
OVERVIEW – in layman’s terms (150 words max)
  This is a study for patients with advanced cholangiocarcinoma or gallbladder cancer. It includes chemotherapy (gemcitabine and cisplatin) with the addition of a PI3K inhibitor to try to improve outcome for this group of patients
Enrollment
  25
Study Start Date
  08/01/2016
Estimated Completion Date
  03/01/2018
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
 
  • To improve the outcome for patients with cholangiocarcinoma or gallbladder cancer
Inclusion Criteria – Patients Must:
 
  • have advanced cholangiocarcinoma or gallbladder cancer
Exclusion Criteria – Patients Must NOT:
 
  • have no previous chemotherapy for their cancer
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
 
  • labs and CT scans
POTENTIAL SIDE-EFFECTS – in layman’s terms
 
  • decreased blood counts, high blood sugar

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