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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00791011 |
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 lymphoma, and Hodgkin's disease.
Part 1 is an open-label, dose-escalation phase (3+3 design) to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with bortezomib or vorinostat. Subjects will be enrolled into one of two arms based on investigator selection (either the bortezomib + AMG 655 arm or vorinostat + AMG 655 arm).
Part 2 of the study is a dose expansion phase that will commence after dose selection of AMG 655 in combination with bortezomib in Part 1. In Part 2, subjects (n = 20) with mantle cell lymphoma will be given AMG 655 in combination with bortezomib. The dose of AMG 655 used in combination with bortezomib will be based on safety and pharmacokinetic information obtained from Part 1 as well as from ongoing AMG 655 trials.
Condition | Intervention | Phase |
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Hodgkin's Lymphoma Low Grade Lymphoma Lymphoma Mantle Cell Lymphoma Non-Hodgkin's Lymphoma Diffuse Large Cell Lymphoma |
Drug: AMG 655 Other: Vorinostat Other: Bortezomib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 62 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cohort 4: Experimental
AMG 655 (intermediate dose) with Vorinostat
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Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
Other: Vorinostat
Vorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC).
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Cohort 1: Experimental
AMG 655 (low dose) with Bortezomib
|
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
Other: Bortezomib
A dipeptide boronic acid analogue with antineoplastic activity.
|
Cohort 2: Experimental
AMG 655 (low dose) with vorinostat
|
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
Other: Vorinostat
Vorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC).
|
Cohort 5: Experimental
AMG 655 (high dose) with Bortezomib
|
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
Other: Bortezomib
A dipeptide boronic acid analogue with antineoplastic activity.
|
Cohort 6: Experimental
AMG 655 (high dose) with Vorinostat
|
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
Other: Vorinostat
Vorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC).
|
Cohort 7: Experimental
Part 2 - Mantle Cell Lymphoma subjects only: AMG 655 at dose TBD with Bortezomib
|
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
Other: Bortezomib
A dipeptide boronic acid analogue with antineoplastic activity.
|
Cohort 3: Experimental
AMG 655 (intermediate dose) with Bortezomib
|
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
Other: Bortezomib
A dipeptide boronic acid analogue with antineoplastic activity.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
United States, California | |
Research Site | Recruiting |
Duarte, California, United States | |
United States, Florida | |
Research Site | Recruiting |
Tampa, Florida, United States | |
United States, Pennsylvania | |
Research Site | Recruiting |
Pittsburgh, Pennsylvania, United States | |
United States, Texas | |
Research Site | Recruiting |
Houston, Texas, United States | |
United States, Washington | |
Research Site | Recruiting |
Tacoma, Washington, United States |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060340 |
Study First Received: | November 13, 2008 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00791011 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Lymphoma AMG 655 Trail receptor Apoptosis |
Vorinostat Bortezomib SAHA Velcade |
Anti-Inflammatory Agents Anticarcinogenic Agents Lymphoma, Mantle-Cell Mantle Cell Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Anti-Inflammatory Agents, Non-Steroidal Analgesics Lymphoma, Large-cell Hodgkin Disease Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Hodgkin Lymphoma, Adult Vorinostat Bortezomib Hodgkin's Disease Protease Inhibitors Lymphatic Diseases B-cell Lymphomas Analgesics, Non-Narcotic Peripheral Nervous System Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs Lymphoma, B-Cell Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Lymphoma Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Vorinostat Bortezomib Enzyme Inhibitors Protective Agents Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents |