Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Immunoproliferative Disorders

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Acalabrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

AstraZeneca Clinical Trials

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).

Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

An Open-label, Phase 1b Study of ACP 196 in Subjects With Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

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Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.

To Characterize the Pharmacokinetic parameter AUC of acalabrutinib

To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib

To evaluate the concentration pharmacodynamic effects of acalabrutinib

To evaluate the activity of acalabrutinib as measured by ORR

Acerta Pharma BV

Acalabrutinib 100mg administered orally (PO) twice daily

Cohort 1 - Relapse Subjects

Cohort 2 - Refractory Subjects

Acalabrutinib 100mg administered orally (PO) twice daily (BID)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

United Kingdom

Region of Enrollment

Study Director

Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.

Spots Global Cancer Trial Database for Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial