Phase 1
N=21
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)
Bottom Line
View on ClinicalTrials.gov: NCT02112526 ↗Enrolled (actual)
21
Serious AEs
42.9%
Results posted
Jul 2020
Primary outcome: Primary: Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL. — 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Acalabrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acerta Pharma BV
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL. |
3; 2 | — |
| SECONDARY Area Under the Plasma Concentration (AUC) |
— | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
— | — |
| SECONDARY Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only) |
— | — |
| SECONDARY Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR) |
— | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Men and women ≥ 18 years of age.
- Pathologically confirmed de novo ABC DLBCL
- Relapsed or refractory disease
- Subjects must have ≥ 1 measurable disease sites
Exclusion Criteria
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF < 50%
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- Breast feeding or pregnant
Data sourced from ClinicalTrials.gov (NCT02112526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.