A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
1 other identifier
interventional
32
1 country
3
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2011
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2011
CompletedFirst Submitted
Initial submission to the registry
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2015
CompletedResults Posted
Study results publicly available
April 10, 2017
CompletedJune 12, 2017
May 1, 2017
4.3 years
October 1, 2013
February 27, 2017
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
From baseline to 30 days after the last dose of study drug
Secondary Outcomes (15)
Number of Participants With Dose Limiting Toxicities
From baseline to 28 days after the first dose of study drug
Maximum Tolerated Dose
From baseline to 28 days after the first dose of study drug
MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose)
Day 0 (pre-dose)
MEDI-551 Trough Concentration Levels at Day 7
Day 7
MEDI-551 Trough Concentration Levels at Day 28
Day 28
- +10 more secondary outcomes
Study Arms (1)
MEDI-551
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Japanese men or women at least 20 years of age
- Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL, or MM.
- Karnofsky Performance Status ≥70;
- Life expectancy of ≥12 weeks
You may not qualify if:
- Any available standard line of therapy known to be life-prolonging or life-saving
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
- Previous therapy directed against CD19, such as monoclonal antibodies or MAb conjugates
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- MedImmune LLCcollaborator
Study Sites (3)
Research Site
Fukuoka, Japan
Research Site
Isehara-shi, Japan
Research Site
Nagoya, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- MedImmune, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2013
First Posted
October 8, 2013
Study Start
May 25, 2011
Primary Completion
September 15, 2015
Study Completion
September 15, 2015
Last Updated
June 12, 2017
Results First Posted
April 10, 2017
Record last verified: 2017-05