Status:
COMPLETED
Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat
Lead Sponsor:
Amgen
Conditions:
Hodgkin's Lymphoma
Low Grade Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multi-center, phase 1b study of AMG 655 in combination with bortezomib or vorinostat in subjects with relapsed or refractory low grade lymphoma, mantle cell lymphoma, diffuse large cell lymp...
Eligibility Criteria
Inclusion
- Part 1: Subjects must have a pathologically confirmed diagnosis of lymphoma that is relapsed or refractory to standard treatment or for which no curative therapy is available. Lymphoma subtypes that are eligible for enrollment include low grade lymphoma, mantle cell lymphoma, diffuse large cell lymphoma, and Hodgkin's disease.
- Part 2: Subjects must have relapsed or refractory mantle cell lymphoma with at least one objective measurable disease site (ie, measurable in at least 2 perpendicular parameters). Subjects must have had at least one prior antineoplastic therapy, up to a maximum of 3. At least one therapy must have included an anthracycline. Subjects must have had documented relapse or progression following the last therapy (ie, most recent therapy given prior to enrollment). An abnormal PET scan will not constitute evaluable disease, unless verified by CT or MRI scan).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic, renal, hepatic and coagulation function
Exclusion
- A history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
- A history of allogeneic stem-cell transplantation
- Primary central nervous system (CNS) tumors including primary CNS lymphoma
- Central nervous system involvement by lymphoma
- Myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (New York Heart Association \>class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- Vorinostat cohorts only: History of significant GI surgery or disease, which would impair intestinal absorption
- Vorinostat cohorts only: Active peptic ulcer disease
- Prior exposure to AMG 655 or other investigational TRAIL receptor agonists is not permitted
- Prior treatment with bortezomib or vorinostat is not permitted for subjects enrolling in the bortezomib and vorinostat cohorts, respectively
- Major surgery within 28 days before the first dose of AMG 655
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00791011
Start Date
February 1 2008
End Date
August 1 2011
Last Update
March 5 2014
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