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SarcomaPhase 2AngioNextNCT00874874

Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery

A Phase 2 study testing sorafenib tosylate in people with Sarcoma, run by Centre Oscar Lambret at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Sarcoma
What is being tested?
sorafenib tosylate
How many people
88 participants
Where
18 sitesFrance
Study dates
23 May 2008to 23 May 2018
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed angiosarcoma
  • Locally advanced or metastatic disease
  • Unresectable disease
  • No Kaposi sarcoma, hemangiopericytoma, or hemangioendothelioma
  • Measurable tumor with at least 1 measurable lesion by RECIST criteria
  • Tumor in a previously irradiated area must not show progression
  • No brain metastases or meningeal tumors (symptomatic or asymptomatic)

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • PT or INR and aPTT ≤ 1.5 times upper limit of normal (ULN)
  • Anticoagulation treatment with heparin or vitamin K allowed if the above criteria are met
  • Liver transaminases ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
  • Total bilirubin ≤ 1.5 times ULN
  • Serum creatinine ≤ 1.5 times ULN
  • Amylase and lipase ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Weight loss from pre-disease weight < 20% over the past 12 months
  • Able to swallow
  • No active or ischemic coronary artery disease
  • No myocardial infarction within the past 6 months
  • No NYHA class III-IV cardiac failure
  • No uncontrolled hypertension
  • No coagulopathy
  • No active uncontrolled peptic ulcer
  • No patients on renal dialysis
  • No active bacterial or fungal infection > CTCAE v3.0 grade 2
  • No HIV or hepatitis B or C positivity
  • No chronic unstable illness that could jeopardize patient safety or compliance
  • No other progressive or malignant tumor
  • No known or suspected allergy to sorafenib tosylate
  • No psychological, familial, social, or geographic situations that preclude clinical follow up
  • No patients deprived of liberty or under guardianship
  • No cardiac arrhythmia requiring antiarrhythmic medication (except beta-blockers or digoxin for chronic atrial fibrillation)
  • No epilepsy requiring antiepileptic drugs

PRIOR CONCURRENT THERAPY:

  • See Patient Characteristics
  • No prior organ or peripheral stem cell transplantation
  • No more than 2 prior lines of chemotherapy
  • At least 28 days since prior treatment (systemic or major surgery)
  • No concurrent therapy for another malignancy
  • No concurrent CYP3A inducers (e.g., rifampicin, St. John wort, phenytoin, carbamazepine, phenobarbital, dexamethasone)

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Hôpital Jean Minjoz

    Besançon, 25503

  • Institut Bergonié

    Bordeaux, 33076

  • Centre François Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli-Calmettes

    Marseille, 13273

  • CHU La Timone

    Marseille, 13385

  • Centre Val d'Aurelle

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie

    Paris, 75005

  • Hôpital Saint-Louis

    Paris, 75010

  • Groupe Hospitalier Cochin Cancer Ouest AP-HP

    Paris, 75619

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre René Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Institut Claudius Regaud

    Toulouse, 31052

Other trials in France

About this study

Official title: Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the rate of non-progression at 9 months in patients with unresectable, locally advanced, or metastatic angiosarcoma treated with sorafenib tosylate.

Secondary

  • Determine the rate of non-progression at 60, 120, and 180 days.
  • Determine the median time to progression.
  • Determine overall survival.
  • Determine the best response rate.
  • Determine the clinical and biological factors that predict clinical benefit.
  • Evaluate tolerability by NCI CTCAE v3.0.
  • Correlate efficacy with plasma expression of genes implicated in controlling angiogenesis.
  • Explore the tumor expression of these genes in tissue from a tumor bank.

OUTLINE: This is a multicenter study.

Patients are stratified according to disease type (cutaneous angiosarcoma [scalp, breast, or soft tissue] vs visceral angiosarcoma). All patients receive oral sorafenib tosylate twice daily for 9 months in the absence of disease progression or unacceptable toxicity.

Conditions
Sarcoma
Being tested
sorafenib tosylate
Keywords
stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult angiosarcoma
Medical subject headings
Sarcoma, Hemangiosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sorafenib tosylateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of non-progression at 9 months by RECIST criteria

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2009 (estimated)
  2. Study start23 May 2008
  3. Primary completion29 Oct 2014
  4. Study completion23 May 2018

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00874874
Sponsor's protocol ID
AngioNext-0710
Other IDs
2007-004651-10, RECF0636, Angio-Next, 2007-10
Acronym
AngioNext
Status last verified
Sep 2026
First submitted
2 Apr 2009
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Penel N, Ray-Coquard I, Bal-Mahieu C, Chevreau C, Le Cesne A, Italiano A, Bompas E, Clisant S, Baldeyrou B, Lansiaux A, Robin YM, Bay JO, Piperno-Neumann S, Blay JY, Fournier C. Low level of baseline circulating VEGF-A is associated with better outcome in patients with vascular sarcomas receiving sorafenib: an ancillary study from a phase II trial. Target Oncol. 2014 Sep;9(3):273-7. doi: 10.1007/s11523-013-0299-0. Epub 2013 Nov 12.

    PubMed 24218035

  • Valentin T, Fournier C, Penel N, Bompas E, Chaigneau L, Isambert N, Chevreau C. Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO). Invest New Drugs. 2013 Dec;31(6):1626-7. doi: 10.1007/s10637-013-0023-z. Epub 2013 Sep 5.

    PubMed 24005614

  • Ray-Coquard I, Italiano A, Bompas E, Le Cesne A, Robin YM, Chevreau C, Bay JO, Bousquet G, Piperno-Neumann S, Isambert N, Lemaitre L, Fournier C, Gauthier E, Collard O, Cupissol D, Clisant S, Blay JY, Penel N; French Sarcoma Group (GSF/GETO). Sorafenib for patients with advanced angiosarcoma: a phase II Trial from the French Sarcoma Group (GSF/GETO). Oncologist. 2012;17(2):260-6. doi: 10.1634/theoncologist.2011-0237. Epub 2012 Jan 27.

    PubMed 22285963

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib tosylate in people with Sarcoma, run by Centre Oscar Lambret at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. 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?

Rate of non-progression at 9 months by RECIST criteria. 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 NCT00874874, which also lists 3 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 17 Sep 2026.

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AngioNext Clinical Trial NCT00874874 | AzTrials