A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients with Relapsed or Refractory Advanced B-cell Malignancies
Study identifier:D2850C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Japanese Adult Patients with Relapsed or Refractory Advanced B-cell Malignancies
Medical condition
Blood Cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI-551
Sex
All
Actual Enrollment
20
Study type
Interventional
Age
20 Years - 150 Years
Date
Study Start Date: 01 May 2011
Estimated Primary Completion Date: 01 Nov 2016
Estimated Study Completion Date: 01 Nov 2016
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 May 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
MedImmune
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI-551 | Drug: MEDI-551 MEDI-551 will be administered by intravenous infusion at dose of 2, 4 or 8 mg/kg once per week on Days 1 and 8 in the first cycle and then once every 28 days at the start of each subsequent cycle |
Contacts
Investigators
Principal Investigator
Trishna Goswami
MedImmune
