An Open-Label, Phase 1b Study of ACP-196 With and Without Dexamethasone in Subjects With Multiple Myeloma
Conditions
Multiple Myeloma (MM)
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Bruton tyrosine kinase inhibitor, Btk, Multiple Myeloma, MM, ACP-196
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ACP-196
Type: Drug
Overall Status
Recruiting
Summary
To characterize the safety profile of ACP-196 with and without dexamethasone in subjects with relapsed or refractory Multiple Myeloma (MM)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 ACP-196, 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
Locations
Baltimore, Maryland, United States
Status: Recruiting
United Kingdom
Leicester, United Kingdom
Status: Not yet recruiting
Start Date
February 2015
Sponsors
Acerta Pharma BV
Source
Acerta Pharma BV
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page