Acalabrutinib

Generic Name: Acalabrutinib

Brand Names: Calquence

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₃N_₇O_₂

CAS Number: 1420477-60-6

Unique Ingredient Identifier: I42748ELQW

Background: To date, acalabrutinib has been used in trials studying the treatment of B-All, myelofibrosis, ovarian cancer, multiple myeloma, and Hodgkin lymphoma, among others.
...

Indication: Acalabrutinib is currently indicated for the treatment of adult patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. It has also been recently approved for chronic lymphocytic leukemia and small lymphocytic lymphoma.

Associated Conditions: Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma (MCL), Small Lymphocytic Lymphoma

Associated Therapies: -

Clinical Trials

Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Ibrutinib
Drug: Venetoclax
Drug: Acalabrutinib

First Posted Date: 2017-04-25

Last Posted Date: 2024-10-29

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 90

Registration Number: NCT03128879

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Phase 3

Active, not recruiting

Conditions: Lymphoma, Mantle Cell

Interventions: Drug: Acalabrutinib
Drug: Bendamustine
Drug: Rituximab
Drug: Placebo

First Posted Date: 2016-11-25

Last Posted Date: 2024-11-29

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 635

Registration Number: NCT02972840

Locations: 🇻🇳
Research Site, Ho Chi Minh, Vietnam

A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Phase 3

Withdrawn

Conditions: Mantle Cell Lymphoma

Interventions: Drug: ibrutinib
Drug: acalabrutinib
Drug: rituximab

First Posted Date: 2016-04-13

Last Posted Date: 2016-05-13

Lead Sponsor: Acerta Pharma BV

Registration Number: NCT02735876

Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)

Phase 2

Completed

Conditions: Ovarian Cancer

Interventions: Drug: acalabrutinib and pembrolizumab combination
Drug: Acalabrutinib

First Posted Date: 2015-09-01

Last Posted Date: 2019-09-25

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 78

Registration Number: NCT02537444

Locations: 🇺🇸
Arizona Gynecology Oncology, Tucson, Arizona, United States
🇺🇸
Jordan Center For Gynecologic Cancer At Penn, Philadelphia, Pennsylvania, United States

Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

Phase 3

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Acalabrutinib
Drug: Ibrutinib

First Posted Date: 2015-06-23

Last Posted Date: 2024-11-01

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 533

Registration Number: NCT02477696

Locations: 🇬🇧
Research Site, Surrey, United Kingdom

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

Phase 3

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Obinutuzumab
Drug: Acalabrutinib
Drug: Chlorambucil

First Posted Date: 2015-06-19

Last Posted Date: 2024-12-19

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 535

Registration Number: NCT02475681

Locations: 🇬🇧
Research Site, Wolverhampton, United Kingdom

Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma

Phase 2

Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: pembrolizumab
Drug: Acalabrutinib

First Posted Date: 2015-05-27

Last Posted Date: 2019-09-12

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 78

Registration Number: NCT02454179

Locations: 🇺🇸
Oregon Health and Science University, Portland, Oregon, United States

Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Pembrolizumab
Drug: Acalabrutinib

First Posted Date: 2015-05-19

Last Posted Date: 2019-09-12

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 74

Registration Number: NCT02448303

Locations: 🇺🇸
Western Regional Medical Center/Cancer Treatment Center of America, Goodyear, Arizona, United States

ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: acalabrutinib

First Posted Date: 2015-03-13

Last Posted Date: 2019-04-02

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 31

Registration Number: NCT02387762

Locations: 🇺🇸
San Marcus Research Clinic, Inc., Hialeah, Florida, United States
🇺🇸
Pinnacle Research Group, Anniston, Alabama, United States
🇺🇸
Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States

and more 14 locations

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

Phase 1

Active, not recruiting

Conditions: CLL
Small Lymphocytic Lymphoma (SLL)
Burkitt Lymphoma
Mediastinal Large B Cell Lymphoma
Richter's Syndrome
Waldenström Macroglobulinemia
Follicular Lymphoma (FL)
Indolent Non Hodgkin Lymphoma
Multiple Myeloma
Marginal Zone Lymphomas

Interventions: Drug: Acalabrutinib
Drug: Pembrolizumab

First Posted Date: 2015-02-12

Last Posted Date: 2024-11-20

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 161

Registration Number: NCT02362035

Locations: 🇺🇸
Research Site, Yakima, Washington, United States

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