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Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02328014
Recruitment Status : Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.

Condition or disease Intervention/treatment Phase
Non-hodgkins Lymphoma Multiple Myeloma B-All Drug: Acalabrutinib Drug: ACP-319 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Proof-of-Concept Study of the Combination of ACP-196 and ACP-319 in Subjects With B-cell Malignancies
Actual Study Start Date : January 13, 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dose Escalation
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.
Drug: Acalabrutinib
Other Name: ACP-196

Drug: ACP-319

Experimental: Expansion
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
Other Name: ACP-196

Drug: ACP-319

Primary Outcome Measures :
  1. Incidence of adverse events from the combination of acalabrutinib and ACP-319 [ Time Frame: From first dose of study drug until 30 days after last dose of study drugs ]
    To characterize the safety profile of acalabrutinib and ACP-319 in subjects with relapsed or refractory B-cell malignancies.

Secondary Outcome Measures :
  1. Area under the plasma concentration (AUC) [ Time Frame: 4 Cycles (1 Cycle = 28 days) ]
    Characterize the Pharmacokinetic parameter AUC of acalabrutinib and ACP-319

  2. Maximum observed plasma concentration (Cmax) [ Time Frame: 4 Cycles (1 Cycle = 28 days) ]
    Characterize the Pharmacokinetic parameter Cmax of acalabrutinib and ACP-319

  3. Evaluate Pharmacodynamic (PD) effects [ Time Frame: 2 Cycles (1 cycle = 28 days) and at end of treatment ]
    To evaluate the concentration pharmacodynamic effects of acalabrutinib and ACP-319

  4. Evaluate Activity of acalabrutinib and ACP-319 [ Time Frame: From enrollment to the date of disease progression, assessed up to 36 Cycles (1 cycle is 28 days) ]
    To evaluate the activity of acalabrutinib as measured by overall response rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • Diagnosis of a b-cell malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO).
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Agreement to use contraception during the study and for 90 days after the last dose of study drugs if sexually active and able to bear or beget children.

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 study drugs, or put the study outcomes at undue risk.
  • Central nervous system (CNS) involvement by lymphoma/leukemia
  • Any therapeutic antibody within 4 weeks of first dose of study drugs.
  • The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drugs is < 5 times the half-life of the previously administered agent(s).
  • ANC < 0.5 x 10^9/L or platelet count < 50 x 10^9/L unless due to disease involvement in the bone marrow.
  • Creatinine > 1.5 x institutional upper limit of normal (ULN); total bilirubin > 1.5 x ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 x ULN.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02328014

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United States, California
Orange, California, United States, 92868
Santa Monica, California, United States, 90404
United States, Maryland
Bethesda, Maryland, United States, 20892
United States, New York
Rochester, New York, United States, 14642
United States, Oregon
Portland, Oregon, United States, 97239
Springfield, Oregon, United States, 97477
United States, Texas
Austin, Texas, United States, 78705
United States, Washington
Seattle, Washington, United States, 98109
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Acerta Pharma BV
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Study Director: Acerta Call Center Acerta Pharma, LLC
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Responsible Party: Acerta Pharma BV Identifier: NCT02328014    
Other Study ID Numbers: ACE-LY-001
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
B-Cell Malignancies
Mantle Cell
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action