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Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma, Soft Tissue

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Trial Information

Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy


Inclusion Criteria:



- Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant
and/or first line anthracycline-based regimen; age >=18 yrs; ECOG PS =2; at least 1
measurable target lesion; life expectancy >=12 wks; adequate medullary liver and
renal function; written informed consent.

Exclusion Criteria:

- metastatic brain disease; pregnant or breast-feeding patients; serious infections.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival rate

Outcome Time Frame:

at 6 months after enrollment

Safety Issue:

Yes

Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas

Authority:

Italy: Ministry of Health

Study ID:

ONC-2006-002

NCT ID:

NCT00406601

Start Date:

November 2006

Completion Date:

September 2010

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma

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