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| Sponsored by: |
Amgen |
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00626704 |
Purpose
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.
| Condition | Intervention | Phase |
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Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma Sarcoma Soft Tissue Sarcoma |
Drug: AMG 655 Other: Placebo |
Phase I Phase II |
| MedlinePlus related topics: | Soft Tissue Sarcoma |
| ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Benzocaine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 90 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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Arm 1: Experimental
AMG 655 + Doxorubicin
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Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
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Arm 2: Placebo Comparator
Placebo + Doxorubicin
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Other: Placebo
Inactive dummy AMG 655 (to maintain blind)
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Amgen Call Center | 866-572-6436 |
| United States, Arizona | |||||
| Research Site | Recruiting | ||||
| Tucson, Arizona, United States | |||||
| United States, California | |||||
| Research Site | Recruiting | ||||
| Duarte, California, United States | |||||
| Research Site | Recruiting | ||||
| Santa Monica, California, United States | |||||
| Research Site | Recruiting | ||||
| Stanford, California, United States | |||||
| Research Site | Recruiting | ||||
| Los Angelas, California, United States | |||||
| United States, Illinois | |||||
| Research Site | Recruiting | ||||
| Evanston, Illinois, United States | |||||
| Research Site | Recruiting | ||||
| Chicago, Illinois, United States | |||||
| United States, Maryland | |||||
| Research Site | Recruiting | ||||
| Baltimore, Maryland, United States | |||||
| United States, Massachusetts | |||||
| Research Site | Recruiting | ||||
| Boston, Massachusetts, United States | |||||
| United States, Minnesota | |||||
| Research Site | Recruiting | ||||
| Rochester, Minnesota, United States | |||||
| United States, Oregon | |||||
| Research Site | Recruiting | ||||
| Portland, Oregon, United States | |||||
| United States, Pennsylvania | |||||
| Research Site | Recruiting | ||||
| Radnor, Pennsylvania, United States | |||||
| Research Site | Recruiting | ||||
| Philadelphia, Pennsylvania, United States | |||||
| United States, Tennessee | |||||
| Research Site | Recruiting | ||||
| Nashville, Tennessee, United States | |||||
| Austria | |||||
| Research Site | Recruiting | ||||
| Wien, Austria | |||||
| Belgium | |||||
| Research Site | Recruiting | ||||
| Brussel, Belgium | |||||
| Research Site | Recruiting | ||||
| Leuven, Belgium | |||||
| France | |||||
| Research Site | Recruiting | ||||
| Villejuif, France | |||||
| Research Site | Recruiting | ||||
| Lyon, France | |||||
| Research Site | Recruiting | ||||
| Marseille, France | |||||
| Netherlands | |||||
| Research Site | Recruiting | ||||
| Leiden, Netherlands | |||||
| Research Site | Recruiting | ||||
| Groningen, Netherlands | |||||
| Amgen |
| Study Director: | MD | Amgen |
More Information
AmgenTrials clinical trials website 
  |
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20060324 |
| First Received: | February 14, 2008 |
| Last Updated: | September 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00626704 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board; United States: Food and Drug Administration; Austria: Competant Authority; Belgium: FPS of Public Health, Food Chain Security and Environment |
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