Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

PHASE2CompletedINTERVENTIONAL
Enrollment

227

Participants

Timeline

Start Date

November 19, 2012

Primary Completion Date

June 22, 2016

Study Completion Date

May 18, 2023

Conditions
Lymphoma, Non-Hodgkin
Interventions
DRUG

Copanlisib (Aliqopa, BAY80-6946)

"BAY 80-6946 is administered in a normal saline solution, 100 mL, intravenously over 1h. No intravenous glucose preparations should be administered on the days of infusion. Dosing is weekly for the first 3 weeks (on Days 1, 8, and 15) of a 28-day cycle, followed by a 1-week break (i.e., no infusion on Day 22).~Part A: The individual dose will be 0.8 mg/kg (max. 65 mg) per infusion from Cycle 1 on. The maximum dose of 65 mg should never be exceeded.~Part B: The individual dose will be 60 mg per infusion from Cycle 1 on."

Trial Locations (102)

1070

Brussels

1083

Budapest

1097

Budapest

1200

Bruxelles - Brussel

1431

Sofia

2300

Turnhout

2605

Garran

2610

Wilrijk

2753

Clinton

3000

Leuven

3080

Seoul

4020

Linz

6351

Seoul

7400

Kaposvár

9000

Ghent

10126

Turin

10967

Berlin

11526

Athens

11590

Westbury

13353

Berlin

14467

Potsdam

20089

Milan

25123

Brescia

28050

Madrid

28222

Majadahonda

29285

Brest

29603

Marbella

33521

Tampere

33600

Pessac

34093

Istanbul

35100

Izmir

35213

Birmingham

35340

Izmir

40138

Bologna

40207

Louisville

41071

Seville

44718

Canton

45659

Recklinghausen

46026

Valencia

48149

Münster

48202

Detroit

49201

Busan

54500

Vandœuvre-lès-Nancy

55131

Mainz

55426

Saint Louis Park

59037

Lille

69495

Pierre-Bénite

75475

Paris

76038

Rouen

78229

San Antonio

80012

Aurora

80113

Englewood

80131

Napoli

80528

Fort Collins

81377

München

85234

Gilbert

85925

La Roche-sur-Yon

86021

Poitiers

90020

Oulu

90801

Anaheim

94010

Créteil

98101

Seattle

129128

Moscow

169608

Singapore

169610

Singapore

197101

Saint Petersburg

410053

Saratov

603126

Nizhny Novgorod

644013

Omsk

650066

Kemerovo

4941492

Petah Tikva

5262000

Ramat Gan

7030000

Ẕerifin

99208-1129

Spokane

E2L 4L2

Saint John

H1T 2M4

Montreal

H3T 1E2

Montreal

00290

Helsinki

FIN-20521

Turku

01307

Dresden

Unknown

Hong Kong

Christchurch

MISSING

Shatin

H91 YR71

Galway

00161

Rome

81-519

Gdynia

30-510

Krakow

1093 CODEX

Lisbon

1099-023

Lisbon

08036

Barcelona

451 80

Uddevalla

06100

Ankara

CB2 0QQ

Cambridge

PL6 8DH

Plymouth

SO16 6YD

Southampton

HA1 3UJ

Harrow

L7 8XP

Liverpool

SM2 5PT

Sutton

B9 5SS

Birmingham

LS9 7TF

Leeds

M20 4BX

Manchester

RM7 0AG

Romford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY