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CompletedNCT00406601Updated Sep 2, 2010

BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas

A Phase 2 interventional study of Sorafenib (BAY-43-9006) in Sarcoma, Soft Tissue, sponsored by Istituto Clinico Humanitas. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-02.

Sponsored by Istituto Clinico Humanitas · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

The aim of this study (*) is to evaluate the progression free survival rate at 6 months, response rate, overall disease control rate, overall survival of BAY-43-9006 in soft tissue sarcoma patients.

(*) as per Protocol Amendment No. 1 of 16 April 2007 approved by local IEC on 24 July 2007

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Conditions studied

  • Sarcoma, Soft Tissue

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03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 69 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (actual)

Interventions

  • DrugSorafenib (BAY-43-9006)

    800 mg/die orally on a continuous basis

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What researchers measure

Primary outcomes

  1. Progression free survival rate

    Time frame: at 6 months after enrollment

Secondary outcomes

  1. Overall response rate, overall disease control rate, overall survival

    Time frame: Tumor assessment, follow-up

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Study locations

1 site
  • Istituto Clinico Humanitas
    Rozzano, Milan 20089, Italy
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References and documents

Publications

  • Antman KH. Adjuvant therapy of sarcomas of soft tissue. Semin Oncol. 1997 Oct;24(5):556-60. PubMed 9344322 ↗
  • Santoro A, Tursz T, Mouridsen H, Verweij J, Steward W, Somers R, Buesa J, Casali P, Spooner D, Rankin E, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1995 Jul;13(7):1537-45. doi: 10.1200/JCO.1995.13.7.1537. PubMed 7602342 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00406601
Lead sponsor
Istituto Clinico Humanitas
First posted
Dec 4, 2006
Start date
Nov 2006
Primary completion
Jun 2010
Completion
Sep 2010
Last update
Sep 2, 2010

Study contacts

Armando Santoro, MD
principal investigator · Istituto Clinico Humanitas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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