Trials / Completed
CompletedNCT00626704
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 655 | AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5). |
| OTHER | Placebo | Inactive dummy AMG 655 (to maintain blind) |
| DRUG | Doxorubicin | Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin. |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2009-08-01
- Completion
- 2011-03-01
- First posted
- 2008-02-29
- Last updated
- 2015-05-25
Source: ClinicalTrials.gov record NCT00626704. Inclusion in this directory is not an endorsement.