Sarcoma, Soft TissuePhase 2NCT00406601
BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas
A Phase 2 study testing Sorafenib (BAY-43-9006) in people with Sarcoma, Soft Tissue, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Sorafenib (BAY-43-9006)
- Type of treatment
- Pill or oral medicine
- How many people
- 69 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2006to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- metastatic brain disease; pregnant or breast-feeding patients; serious infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy
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
- Sarcoma, Soft Tissue
- Being tested
- Sorafenib (BAY-43-9006)
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (BAY-43-9006)Drug
800 mg/die orally on a continuous basis
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate
Measured: at 6 months after enrollment
Secondary outcomes (1)
Overall response rate, overall disease control rate, overall survival
Measured: Tumor assessment, follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406601
- Sponsor's protocol ID
- ONC-2006-002
- Other IDs
- EUDRACT 2006-004437-15
- Status last verified
- Sep 2010
- First submitted
- 29 Nov 2006
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Antman KH. Adjuvant therapy of sarcomas of soft tissue. Semin Oncol. 1997 Oct;24(5):556-60.
PubMed 9344322Santoro 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Prospective Study With BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas, After Anthracycline-based Therapy
- ClinicalTrials.gov ID
- NCT00406601
- Acronym / sponsor ID
- ONC-2006-002
- Conditions
- Sarcoma, Soft Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- metastatic brain disease; pregnant or breast-feeding patients; serious infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib (BAY-43-9006)800 mg/die orally on a continuous basis | Drug | – |
Primary outcome
Progression free survival rate
Time frame: at 6 months after enrollment
1 secondary outcome
Overall response rate, overall disease control rate, overall survival
Time frame: Tumor assessment, follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
- Background: PubMed 9344322Antman KH. Adjuvant therapy of sarcomas of soft tissue. Semin Oncol. 1997 Oct;24(5):556-60.
- Background: PubMed 7602342Santoro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib (BAY-43-9006) in people with Sarcoma, Soft Tissue, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival rate (time frame: at 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406601, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2010.