458
Participants
Start Date
August 3, 2015
Primary Completion Date
August 31, 2020
Study Completion Date
November 15, 2024
Copanlisib (Aliqopa, BAY80-6946)
Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. Dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered before rituximab.
Placebo
Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Placebo will be administered before rituximab.
Rituximab
Rituximab dose 375 mg/m2 body surface weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day 1 of Cycles 3, 5, 7 and 9.The solution for IV infusions is obtained after reconstitution of a calculated concentration of 1 to 4 mg/ml rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/ml (0.9%) solution for injection or 5% D-Glucose in water.
Chai Wan
Taipei
Tainan City
Kaohsiung City
Budapest
Vienna
City of Taguig
Vienna
Dresden
Ottignies
Pasig
Sofia
Johannesburg
Tatabánya
Seoul
Tauranga
Ballarat
Plovdiv
Nedlands
Ankara
Halle
Nice
George
Kaposvár
Pécs
Graz
Barcelona
Varna
Győr
Hà Nội
New York
Pathum Thani
Pulau Pinang
Bucharest
Berlin
Taipei
Athens
Chaïdári
Genoa
Cherkasy
Bucharest
Milan
Bethesda
Málaga
Vinnitsa
Bucharest
Pátrai
Madrid
Majadahonda
Brest
Bucharest
Perak
Udine
Pessac
Istanbul
Izmir
Salamanca
Kayseri
Louisville
Ashland
Canton
Saint-Herblain
Recklinghausen
Dnipro
Busan
Busan
Changhua
Florence
Chiang Mai
Cheras
Metz
Hwasun Gun
Morelia
Kuala Lumpur
Trabzon
Bayonne
Monterrey
Kuala Selangor
Ho Chi Minh City
Lviv
München
Salt Lake City
Poitiers
Kota Kinabalu
Las Vegas
West Covina
Spokane
Beijing
Beijing
Beijing
Beijing
Shengyang
Bogota
Singapore
Changchun
Singapore
Singapore
Saint Petersburg
Shanghai
Shanghai
Shanghai
Craiova
Nanjing
Suzhou
Montería
Tianjin
Tianjin
Hangzhou
Hangzhou
Nanchang
Fuzhou
Cluj-Napoca
Chongqing
Chongqing
Volgograd
Kazan'
Wuhan
Chelyabinsk
Brasov
Guangzhou
Târgu Mureş
Kirov
Chengdu
Novosibirsk
Omsk
Kemerovo
Irkutsk
Santiago de Cali
Ürümqi
Temuco
Montvale
MSK Basking Ridge, New Jersey
MSK Bergen, New Jersey
MSK Monmoth, New Jersey
MSK Westchester, Harrison
MSK Commack, Long Island City
MSK Rockville Centre, Long Island City
Buenos Aires
Guangzhou
Rosario
San Miguel de Tucumán
Córdoba
Passo Fundo
Porto Alegre
Barretos/SP
Jaú
São Paulo
São Paulo
São Paulo
São Paulo
Medellín
Athens
Hong Kong
Dublin
Dublin
Galway
Nagoya
Nagoya
Maebashi
Kobe
Nankoku
Sendai
Ōmura
Kurashiki
Hirakata
Izumo
Chuo-ku
Aomori
Fukuoka
Kumamoto
Niigata
Osaka
Yamagata
Kaunas
Gdansk
Gdynia
Krakow
Lublin
Porto
Porto
Poprad
Seoul
Seoul
Seoul
Barcelona
Barcelona
Kyiv
Lead Sponsor
Bayer
INDUSTRY