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An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma

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.
 
ClinicalTrials.gov Identifier: NCT02211014
Recruitment Status : Completed
First Posted : August 7, 2014
Results First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
Acerta Pharma, LLC
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
To characterize the safety profile of acalabrutinib with and without dexamethasone in subjects with relapsed or refractory Multiple Myeloma (MM)

Condition or disease Intervention/treatment Phase
Multiple Myeloma (MM) Drug: acalabrutinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 1b Study of ACP-196 With and Without Dexamethasone in Subjects With Multiple Myeloma
Actual Study Start Date : February 2015
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Cohort 1
Acalabrutinib 100 mg twice daily (bid) continuously
Drug: acalabrutinib
Other Name: ACP-196

Experimental: Cohort 2
Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
Drug: acalabrutinib
Other Name: ACP-196




Primary Outcome Measures :
  1. Characterize the Safety Profile of Acalabrutinib With and Without Dexamethasone in Subjects With Relapsed or Refractory MM [ Time Frame: From first dose of study drug to within 30 days of last dose of study drug ]
    Safety was assessed by AEs, including SAEs and AEs of clinical interest; hematology, clinical chemistry and other laboratory variables; vital signs and ECOG PS scores.


Secondary Outcome Measures :
  1. Characterize the PK Profile of Acalabrutinib With and Without Dexamethasone and the PK Profile of Dexamethasone With Concomitant Acalabrutinib Administration [ Time Frame: From first dose of study drug to within 30 days of last dose of study drug ]
    Noncompartmental PK parameters were calculated for acalabrutinib and dexamethasone based on plasma concentrations.

  2. Evaluate the Pharmacodynamic Effects of Acalabrutinib With and Without Dexamethasone [ Time Frame: From first dose of study drug to within 30 days of last dose of study drug ]
    BTK occupancy and B-cell activation were assessed.

  3. Evaluate the Activity of Acalabrutinib With and Without Dexamethasone as Measured by ORR, DOR, Clinical Benefit Rate, Disease Control Rate, and PFS [ Time Frame: From first dose of study drug to within 30 days of last dose of study drug ]
    ORR, DOR, clinical benefit rate, disease control rate and PFS as assessed by the investigator according to the current guidelines proposed by the International Myeloma Workshop Consensus Panel 1 (Rajkumar et al 2011) and European Group for Blood and Marrow Transplant (EBMT; Bladé et al 1998).



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

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • A confirmed diagnosis of MM, which has relapsed after, or been refractory to ≥ 1 prior therapy for MM, and is progressing at the time of study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Agreement to use contraception during the study and for 30 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 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
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Breast feeding or pregnant

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 ClinicalTrials.gov identifier (NCT number): NCT02211014


Locations
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United States, Maryland
Baltimore, Maryland, United States
United Kingdom
United Kingdom
Leicester, United Kingdom
Guys and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Acerta Pharma BV
Acerta Pharma, LLC
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613
  Study Documents (Full-Text)

Documents provided by Acerta Pharma BV:
Study Protocol  [PDF] January 13, 2016
Statistical Analysis Plan  [PDF] September 20, 2018

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02211014    
Other Study ID Numbers: ACE-MY-001
First Posted: August 7, 2014    Key Record Dates
Results First Posted: May 13, 2020
Last Update Posted: May 13, 2020
Last Verified: April 2020
Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Btk
Multiple Myeloma
MM
ACP-196
acalabrutinib
Calquence
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases