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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, Sarcoma, Soft Tissue Sarcoma

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Trial Information

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


Inclusion Criteria:



- Histologically or cytologically confirmed soft tissue sarcoma

- Locally advanced, recurrent, or metastatic, unresectable disease

- Measurable disease according to modified RECIST

- ECOG performance status of 0 or 1

- Men or women at least 18 years of age

- Adequate hematological, renal, hepatic, and coagulation function

Exclusion Criteria:

- Prior treatment with anthracyclines

- Uncontrolled cardiovascular disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Time Frame:

Length of Study

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Austria: Competant Authority

Study ID:

20060324

NCT ID:

NCT00626704

Start Date:

November 2007

Completion Date:

May 2012

Related Keywords:

  • Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
  • Sarcoma
  • Soft Tissue Sarcoma
  • Sarcoma
  • Soft Tissue Sarcoma
  • Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
  • AMG 655
  • STS
  • Doxorubicin
  • Death receptor
  • TRAIL receptor
  • Apoptosis
  • Sarcoma

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