Trials / Active Not Recruiting
Active Not RecruitingNCT02180724
An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Acerta Pharma BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acalabrutinib (ACP-196) | |
| DRUG | Acalabrutinib (ACP-196) |
Timeline
- Start date
- 2014-09-11
- Primary completion
- 2019-10-01
- Completion
- 2026-12-31
- First posted
- 2014-07-03
- Last updated
- 2026-03-20
- Results posted
- 2020-04-24
Locations
38 sites across 7 countries: United States, France, Greece, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02180724. Inclusion in this directory is not an endorsement.