Study identifier:ACE-LY-001
ClinicalTrials.gov identifier:NCT02328014
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1/2 Proof-of-Concept Study of the Combination of ACP-196 and ACP-319 in Subjects With B-cell Malignancies
Non-Hodgkins Lymphoma
Phase 1/2
No
Acalabrutinib, ACP-319
All
40
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jul 2024 by AcertaPharma
AcertaPharma
AstraZeneca
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Dose Escalation and Expansion The acalabrutinib dose will be fixed and the ACP-319 dose will be escalated in each of three cohorts, and each cohort will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals. Expansion groups of up to 12 subjects for Germinal center B-cell (GCB) DLBCL and Non-GCB DLBCL to take a fixed dose of acalabrutinib and ACP-319. Each disease group will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals. | Drug: Acalabrutinib Oral Other Name: ACP-196 Drug: ACP-319 Oral Other Name: Not Applicable |