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 : Completed
First Posted : August 7, 2014
Results First Posted : May 13, 2020
Last Update Posted : May 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma (MM)||Drug: acalabrutinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Cohort 1
Acalabrutinib 100 mg twice daily (bid) continuously
Other Name: ACP-196
Experimental: Cohort 2
Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
Other Name: ACP-196
- 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.
- 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.
- 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.
- 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).
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
|United States, Maryland|
|Baltimore, Maryland, United States|
|Leicester, United Kingdom|
|Guys and St Thomas' Hospital NHS Foundation Trust|
|London, United Kingdom|
|Study Director:||Acerta Clinical Trials||1-888-292-9613|