NCT00634452CompletedPhase 1
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
Bristol-Myers Squibb6 sites in 1 country22 target enrollmentStarted: February 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 6
- Primary Endpoint
- Safety and Tolerability Profile
Study Overview
Brief Summary
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
MDX-1401
Experimental
MDX-1401 iv at various doses
Intervention: MDX-1401 (Biological)
Outcomes
Primary Outcomes
Safety and Tolerability Profile
Time Frame: Two years
Secondary Outcomes
- Objective Response Rate (ORR)(Day 50)
- Tumor response assessment(Two year)
Investigators
Study Sites (6)
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