BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas
This study has been completed.
Sponsor:
Istituto Clinico Humanitas
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00406601
First received: November 29, 2006
Last updated: September 1, 2010
Last verified: September 2010
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma, Soft Tissue |
Drug: Sorafenib (BAY-43-9006) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy |
Resource links provided by NLM:
Further study details as provided by Istituto Clinico Humanitas:
Primary Outcome Measures:
- Progression free survival rate [ Time Frame: at 6 months after enrollment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall response rate, overall disease control rate, overall survival [ Time Frame: Tumor assessment, follow-up ] [ Designated as safety issue: Yes ]
| Enrollment: | 69 |
| Study Start Date: | November 2006 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Sorafenib (BAY-43-9006)
800 mg/die orally on a continuous basis
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
Publications:
| Responsible Party: | Armando Santoro, MD, Istituto Clinico Humanitas |
| ClinicalTrials.gov Identifier: | NCT00406601 History of Changes |
| Other Study ID Numbers: | ONC-2006-002, EUDRACT 2006-004437-15 |
| Study First Received: | November 29, 2006 |
| Last Updated: | September 1, 2010 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sorafenib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013