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

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ClinicalTrials.gov Identifier: NCT02328014
Recruitment Status : Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE December 18, 2014
First Posted Date  ICMJE December 31, 2014
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE January 13, 2015
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 26, 2014)
Incidence of adverse events from the combination of ACP-196 and ACP-319 [ Time Frame: up to 12 month ]
Change History Complete list of historical versions of study NCT02328014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • Area under the plasma concentration (AUC) [ Time Frame: 4 Cycles (1 Cycle = 28 days) ]
    Characterize the Pharmacokinetic parameter AUC of acalabrutinib and ACP-319
  • Maximum observed plasma concentration (Cmax) [ Time Frame: 4 Cycles (1 Cycle = 28 days) ]
    Characterize the Pharmacokinetic parameter Cmax of acalabrutinib and ACP-319
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2014)
Overall response rate of the combination of ACP-196 and ACP-319 [ Time Frame: Up to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies
Official Title  ICMJE A Phase 1/2 Proof-of-Concept Study of the Combination of ACP-196 and ACP-319 in Subjects With B-cell Malignancies
Brief Summary This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-hodgkins Lymphoma
  • Multiple Myeloma
  • B-All
Intervention  ICMJE
  • Drug: Acalabrutinib
    Oral
    Other Name: ACP-196
  • Drug: ACP-319
    Oral
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Acalabrutinib
    • 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.
    Interventions:
    • Drug: Acalabrutinib
    • Drug: ACP-319
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 20, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: December 26, 2014)
126
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02328014
Other Study ID Numbers  ICMJE ACE-LY-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acerta Pharma BV
Study Sponsor  ICMJE Acerta Pharma BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Acerta Call Center Acerta Pharma, LLC
PRS Account Acerta Pharma BV
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP