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Trials / Active Not Recruiting

Active Not RecruitingNCT02717611

A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Acerta Pharma BV · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

A Multicenter, Open-Label, Phase 2 study evaluating the efficacy and safety of Acalabrutinib in subjects with relapsed/refractory CLL (N=60) who are intolerant of ibrutinib therapy.

Conditions

Interventions

TypeNameDescription
DRUGACP-196 (acalabrutinib)ACP-196 100 mg to be administered orally (PO) twice a day BID.

Timeline

Start date
2016-03-08
Primary completion
2020-10-16
Completion
2026-06-06
First posted
2016-03-24
Last updated
2026-03-25
Results posted
2022-02-09

Locations

23 sites across 6 countries: United States, Belgium, France, Israel, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT02717611. Inclusion in this directory is not an endorsement.