Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
MDX1401-01
A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
2 other identifiers
interventional
22
1 country
6
Brief Summary
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2008
6 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
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedDecember 6, 2012
December 1, 2012
1.9 years
February 26, 2008
December 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability Profile
Two years
Secondary Outcomes (2)
Objective Response Rate (ORR)
Day 50
Tumor response assessment
Two year
Study Arms (1)
MDX-1401
EXPERIMENTALMDX-1401 iv at various doses
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
- Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
- Bi-measurable disease
- ECOG Performance Status of 0 - 2
- Meet all screening laboratory values
You may not qualify if:
- Previous treatment with any other anti-CD30 antibody
- History of allogeneic transplant
- Any tumor lesion greater than or equal to 10 cm in diameter
- Any active or chronic significant infection
- Underlying medical condition which will make the administration of MDX- 1401 hazardous
- Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
ClinWorks Cancer Research Center
Charlotte, North Carolina, 28207, United States
Scott and White Memorial Hospital and Clinic
Temple, Texas, 76508, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
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
February 26, 2008
First Posted
March 13, 2008
Study Start
February 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
December 6, 2012
Record last verified: 2012-12