Copanlisib (Aliqopa, BAY80-6946)

DRUG8 trials

Conditions

CancerDiffuse, Large B-Cell, LymphomaHealthy VolunteersHepatic Insufficiency, Renal InsufficiencyLymphoma, Non-HodgkinLymphoma,Non-HodgkinNeoplasms

Phase 1

BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer

CompletedNCT00962611

BayerNeoplasms

Start: 2009-11-19End: 2016-02-23Updated: 2017-10-06

Study of Copanlisib in Hepatic or Renal Impairment

CompletedNCT03172884

BayerHepatic Insufficiency, Renal Insufficiency

Start: 2017-06-14End: 2020-05-15Updated: 2021-04-28

Copanlisib Chinese PK Study

CompletedNCT03498430

BayerLymphoma, Non-Hodgkin

Start: 2018-04-27End: 2020-06-02Updated: 2021-05-19

Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics

CompletedNCT03655301

BayerHealthy Volunteers

Start: 2018-09-11End: 2019-02-12Updated: 2020-01-28

Phase 2

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

CompletedNCT01660451

BayerLymphoma, Non-Hodgkin

Start: 2012-11-19End: 2023-05-18Updated: 2024-07-17

Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

CompletedNCT02391116

BayerDiffuse, Large B-Cell, Lymphoma

Start: 2015-05-08End: 2018-01-19Updated: 2019-01-04

Phase 3

Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)

CompletedNCT02367040

BayerLymphoma,Non-Hodgkin

Start: 2015-08-03End: 2024-11-15Updated: 2025-10-14

Unknown Phase

Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors

NCT06238583

BayerCancer

Updated: 2024-02-02

2024-11-124 citations

Six-year safety and efficacy results from the CHRONOS-1 study of the PI3K inhibitor copanlisib in patients with relapsed or refractory follicular lymphoma.

Journal of Clinical Oncology2023-06-013 citations

PB2132: COPANLISIB PLUS RITUXIMAB-BENDAMUSTINE FOR RELAPSED-REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA: RECRUITMENT UPDATE ON AN ONGOING PHASE II TRIAL OF THE FONDAZIONE ITALIANA LINFOMI (FIL_COPA-RB)

HemaSphere2022-06-01

A phase I pharmacokinetic study of copanlisib in Chinese patients with relapsed indolent non-Hodgkin lymphoma.

2022-03-234 citations

Abstract CT001: CHRONOS-3: Randomized Phase III study of copanlisib plus rituximab vs rituximab/placebo in relapsed indolent non-Hodgkin lymphoma (iNHL)

Cancer Research2021-07-01

COPANLISIB IN COMBINATION WITH RITUXIMAB‐BENDAMUSTINE IN PATIENTS WITH RELAPSED‐REFRACTORY DLBCL: A MULTICENTRIC PHASE II TRIAL OF THE FONDAZIONE ITALIANA LINFOMI

Hematological Oncology2021-06-012 citations

CHRONOS‐3: RANDOMIZED PHASE III STUDY OF COPANLISIB PLUS RITUXIMAB <i>VS</i> RITUXIMAB/PLACEBO IN RELAPSED INDOLENT NON‐HODGKIN LYMPHOMA (INHL)

Hematological Oncology2021-06-01

Copanlisib + rituximab versus rituximab + placebo in patients with relapsed follicular (FL) or marginal zone lymphoma (MZL): Subset analysis from the phase III CHRONOS-3 trial.

Journal of Clinical Oncology2021-05-20

Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial.

2021-04-10102 citations

Efficacy and safety of copanlisib in patients with relapsed or refractory marginal zone lymphoma

Blood Advances2021-02-0530 citations

Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma.

2020-02-1453 citations

Copanlisib, a PI3K Inhibitor, Demonstrates a Favorable Long-Term Safety Profile in a Pooled Analysis of Patients with Hematologic Malignancies

Blood2019-11-138 citations

Long-Term Efficacy and Safety of Copanlisib in Multiply Relapsed or Refractory Patients with Marginal Zone Lymphoma

Blood2019-11-133 citations

EFFICACY AND SAFETY IN HIGH‐RISK RELAPSED OR REFRACTORY INDOLENT FOLLICULAR LYMPHOMA PATIENTS TREATED WITH COPANLISIB

Hematological Oncology2019-06-017 citations

COPANLISIB TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA

Hematological Oncology2019-06-01

Long-term follow-up of patients (pts) with relapsed or refractory (r/r) follicular lymphoma (FL) treated with copanlisib.

Journal of Clinical Oncology2019-05-201 citations

Copanlisib monotherapy activity in relapsed or refractory indolent B-cell lymphoma: Combined analysis from phase I and II studies

Annals of Oncology2018-10-01

Copanlisib treatment in patients with relapsed or refractory indolent B-cell lymphoma: Subgroup analyses of diabetic patients from the phase II CHRONOS-1 study.

Journal of Clinical Oncology2018-05-201 citations

PI3K Inhibition in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Oncology Times2018-02-09

PI3K Inhibitor Shows Promise for Patients With Relapsed/Refractory Disease

Oncology Times2017-10-31

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