Neoplasms

All Conditions

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Sarcoma

Death

Ichthyosis, X-Linked

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Central Nervous System Depressants

Other Dietary Supplements

Antibodies

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Daunorubicin

Antibiotics, Antitubercular

Immunoglobulins

Benzocaine

Conatumumab

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Tannic Acid

AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).

AMG 655

Inactive dummy AMG 655 (to maintain blind)

Placebo

Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.

This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.

Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma

A Phase 1b/2 Study of AMG 655 in Combination With Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma

Amgen

Blood and Lymph Conditions

Immune System Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, Mantle-Cell

Hodgkin Disease

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, B-Cell

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Mantle Cell Lymphoma

Hodgkin Lymphoma

B-cell Lymphoma

Bortezomib

Vorinostat

Histone Deacetylase Inhibitors

AMG 655 (intermediate dose) with Vorinostat

Part 2 - Mantle Cell Lymphoma subjects only: AMG 655 at dose TBD with Bortezomib

AMG 655 (intermediate dose) with Bortezomib

AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).

Vorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC).

A dipeptide boronic acid analogue with antineoplastic activity.

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.

Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma	NCT00626704	Locally Advance... Sarcoma Soft Tissue Sar...	AMG 655 Placebo Doxorubicin	18 Years -	Amgen
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma	NCT00626704	Locally Advance... Sarcoma Soft Tissue Sar...	AMG 655 Placebo Doxorubicin	18 Years -	Amgen
Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat	NCT00791011	Hodgkin's Lymph... Low Grade Lymph... Lymphoma Mantle Cell Lym... Non-Hodgkin's L... Diffuse Large C...	AMG 655 Vorinostat Bortezomib	18 Years -	Amgen
Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat	NCT00791011	Hodgkin's Lymph... Low Grade Lymph... Lymphoma Mantle Cell Lym... Non-Hodgkin's L... Diffuse Large C...	AMG 655 Vorinostat Bortezomib	18 Years -	Amgen

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