Clinical trials: sponsored by Acerta Pharma BV
Chronic Lymphocytic Leukemia
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).
- Trial name
- NCT02970318
- Testing
- Acalabrutinib (ACP-196), Rituximab, Idelalisib
- Where
- 157 sites in United States, Australia and 23 more
- Volunteers
- 310 people
- Sponsor
- Acerta Pharma BV
Non Hodgkin Lymphoma
Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL. Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects…
- Trial name
- NCT02180711
- Testing
- acalabrutinib, rituximab (IV), Lenalidomide
- Where
- 29 sites in United States, Canada and 1 more
- Volunteers
- 113 people
- Sponsor
- Acerta Pharma BV
Waldenström Macroglobulinemia (WM)
An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.
- Trial name
- NCT02180724
- Testing
- Acalabrutinib (ACP-196)
- Where
- 38 sites in United States, France and 5 more
- Volunteers
- 107 people
- Sponsor
- Acerta Pharma BV
Chronic Lymphocytic Leukemia
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
- Trial name
- NCT02477696
- Testing
- Acalabrutinib, Ibrutinib
- Where
- 130 sites in United States, Australia and 13 more
- Volunteers
- 533 people
- Sponsor
- Acerta Pharma BV
Chronic Lymphocytic Leukemia
Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL
This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic…
- Trial name
- ElevateTN (NCT02475681)
- Testing
- Acalabrutinib, Obinutuzumab, Chlorambucil
- Where
- 155 sites in United States, Australia and 16 more
- Volunteers
- 535 people
- Sponsor
- Acerta Pharma BV
Mantle Cell Lymphoma (MCL)
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).
- Trial name
- NCT02213926
- Testing
- ACP-196 (acalabrutinib)
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 124 people
- Sponsor
- Acerta Pharma BV
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Trial name
- NCT02337829
- Testing
- Acalabrutinib (Arm A), Acalabrutinib (Arm B)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Acerta Pharma BV
Follicular Lymphoma (FL), CLL
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.
- Conditions
- Follicular Lymphoma (FL), CLL, Small Lymphocytic Lymphoma (SLL), Richter's Syndrome
- Trial name
- KEYNOTE145 (NCT02362035)
- Testing
- Acalabrutinib, Pembrolizumab
- Where
- 19 sites in United States
- Volunteers
- 161 people
- Sponsor
- Acerta Pharma BV
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
This study is evaluating the safety and efficacy of a new BTK inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Prolymphocytic Leukemia
- Trial name
- NCT02029443
- Testing
- Acalabrutinib
- Where
- 12 sites in United States, Italy and 1 more
- Volunteers
- 306 people
- Sponsor
- Acerta Pharma BV
Glioblastoma Multiforme
A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)
A Phase 1b/2, Multicenter, Open-Label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM)
- Trial name
- NCT02586857
- Testing
- ACP-196
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Acerta Pharma BV
Chronic Lymphocytic Leukemia
A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
- Trial name
- NCT02717611
- Testing
- ACP-196 (acalabrutinib)
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Acerta Pharma BV
Non-Hodgkins Lymphoma, Multiple Myeloma
Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.
- Conditions
- Non-Hodgkins Lymphoma, Multiple Myeloma, B-All
- Trial name
- NCT02328014
- Testing
- Acalabrutinib, ACP-319
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Acerta Pharma BV
Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).
- Trial name
- NCT02112526
- Testing
- Acalabrutinib
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 21 people
- Sponsor
- Acerta Pharma BV
COVID-19
Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19
Study D822FC00005 will investigate the Phamacokinetics, Safety and tolerability of Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a Proton Pump Inhibitor, in the treatment of COVID-19.
- Trial name
- NCT04497948
- Testing
- Acalabrutinib
- Where
- 4 sites in Brazil
- Volunteers
- 9 people
- Sponsor
- Acerta Pharma BV
Hepatic Impairment, Hepatic Insufficiency
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
- Conditions
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT03968848
- Testing
- acalabrutinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
DLBCL, Richter Syndrome
A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies
This study evaluates the safety of acalabrutinib and vistusertib when taken in combination.
- Trial name
- NCT03205046
- Testing
- acalabrutinib, vistusertib
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Acerta Pharma BV
Multiple Myeloma (MM)
An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma
To characterize the safety profile of acalabrutinib with and without dexamethasone in subjects with relapsed or refractory Multiple Myeloma (MM)
- Trial name
- NCT02211014
- Testing
- acalabrutinib
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 27 people
- Sponsor
- Acerta Pharma BV
Metastatic Pancreatic Cancer
ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer
- Trial name
- KEYNOTE144 (NCT02362048)
- Testing
- ACP-196, ACP-196 in combination with pembrolizumab
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Acerta Pharma BV
Ovarian Cancer
Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)
To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer
- Trial name
- NCT02537444
- Testing
- Acalabrutinib, acalabrutinib and pembrolizumab combination
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Acerta Pharma BV
Carcinoma, Non-Small-Cell Lung
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.
- Trial name
- KEYNOTE166 (NCT02448303)
- Testing
- Pembrolizumab, Acalabrutinib
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Acerta Pharma BV