Status:
COMPLETED
An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma
Lead Sponsor:
Acerta Pharma BV
Collaborating Sponsors:
Acerta Pharma, LLC
Conditions:
Multiple Myeloma (MM)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To characterize the safety profile of acalabrutinib with and without dexamethasone in subjects with relapsed or refractory Multiple Myeloma (MM)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2019
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02211014
Start Date
February 1 2015
End Date
April 26 2019
Last Update
July 31 2020
Active Locations (3)
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1
Baltimore, Maryland, United States
2
United Kingdom
Leicester, United Kingdom
3
Guys and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom