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

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ClinicalTrials.gov Identifier: NCT02211014
Recruitment Status : Active, not recruiting
First Posted : August 7, 2014
Last Update Posted : March 5, 2018
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

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
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: acalabrutinib Regimen 1
Acalabrutinib Regimen 1
Drug: acalabrutinib
Other Name: ACP-196

Experimental: acalabrutinib Regimen 1 plus dexamethasone
acalabrutinib Regimen 1 plus dexamethasone
Drug: acalabrutinib
Other Name: ACP-196




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: From first dose of study drug to within 30 days of last dose of study drug ]


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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
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
Study Director: Ruth Penn Acerta Pharma, LLC

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02211014     History of Changes
Other Study ID Numbers: ACE-MY-001
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Btk
Multiple Myeloma
MM
ACP-196
acalabrutinib

Additional relevant MeSH terms:
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
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors