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A Phase 1b Study to Evaluate the Safety and Tolerability of AMG 655 in Combination With Bortezomib or Vorinostat in Subjects With Relapsed or Refractory Lymphoma

Phase 1
18 Years
Not Enrolling
Hodgkin's Lymphoma, Low Grade Lymphoma, Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, Diffuse Large Cell Lymphoma

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Trial Information

A Phase 1b Study to Evaluate the Safety and Tolerability of AMG 655 in Combination With Bortezomib or Vorinostat in Subjects With Relapsed or Refractory Lymphoma

Inclusion Criteria:

- 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 Criteria:

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 1: Safety: Subject incidence of treatment emergent adverse events, Dose Limiting Toxicities, the severity of adverse events and clinically significant changes in safety laboratory tests, physical examinations, or vital signs.

Outcome Time Frame:

Length of Study

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

March 2011

Related Keywords:

  • Hodgkin's Lymphoma
  • Low Grade Lymphoma
  • Lymphoma
  • Mantle Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Diffuse Large Cell Lymphoma
  • Lymphoma
  • AMG 655
  • Trail receptor
  • Apoptosis
  • Vorinostat
  • Bortezomib
  • SAHA
  • Velcade
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell