Spots Global Cancer Trial Database for An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia
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Trial Identification
Brief Title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia
Official Title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia
Study ID: NCT02180724
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.
Detailed Description: Clinical studies have shown that targeting the B-cell receptor (BCR) signaling pathway by inhibiting Bruton tyrosine kinase (BTK) produces significant clinical benefit in patients with non-Hodgkin lymphoma, including Waldenström macroglobulinemia (WM). Ibrutinib (IMBRUVICA®), an oral, small-molecule BTK inhibitor has been approved for the treatment for chronic lymphocytic leukemia (CLL), mantle cell lymphoma, and WM. Acerta Pharma BV (AcertaPharma) has developed a novel BTK inhibitor, acalabrutinib, that achieves significant oral bioavailability and potency in preclinical models. The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Santa Barbara, California, United States
Research Site, Aurora, Colorado, United States
Research Site, Washington, District of Columbia, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, New York, New York, United States
Research Site, Nashville, Tennessee, United States
Research Site, Austin, Texas, United States
Research Site, Bedford, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Vancouver, Washington, United States
Research Site, Aurillac Cedex, , France
Research Site, Clermond Ferrand, , France
Research Site, Marseille CEDEX, , France
Research Site, Montpellier, , France
Research Site, Nantes, , France
Research Site, Paris cedex 13, , France
Research Site, Paris, , France
Research Site, Pierre Benite Cedex, , France
Research Site, Poitiers, , France
Research Site, Reims Cedex, , France
Research Site, Rennes Cedex, , France
Research Site, Toulouse Cedex, , France
Research Site, Vandoeuvre-les-Nancy, , France
Research Site, Athens, , Greece
Research Site, Bologna, , Italy
Research Site, Milan, , Italy
Research Site, Novara, , Italy
Research Site, Amsterdam, , Netherlands
Research Site, Utrecht, , Netherlands
Research Site, Salamanca, , Spain
Research Site, Bournemouth, , United Kingdom
Research Site, Leeds, , United Kingdom
Research Site, Leicester, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Oxford, , United Kingdom
Research Site, Plymouth, , United Kingdom
Research Site, Southampton, , United Kingdom
Contact Details
Name: AstraZeneca Clinical study Information Center
Affiliation: 1-877-240-9479 information.center@astrazeneca.com
Role: STUDY_DIRECTOR
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