Clinical trial · Interventional
BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas
Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy
NCT00406601CI-TRIAL-00003865completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (BAY-43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival rate
- timeFrame
- at 6 months after enrollment
Secondary outcomes (1)
- measure
- Overall response rate, overall disease control rate, overall survival
- timeFrame
- Tumor assessment, follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDAntman KH. Adjuvant therapy of sarcomas of soft tissue. Semin Oncol. 1997 Oct;24(5):556-60. PMID 9344322
- BACKGROUNDSantoro 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. PMID 7602342