Can a Blood-Flow-Blocking drug stall a rare sarcoma?

NCT ID NCT00874874

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing sorafenib, a drug that blocks enzymes tumors need to grow and cuts off their blood supply, in people with angiosarcoma that is locally advanced, has spread, or cannot be removed by surgery. The trial enrolls about 88 participants and measures how many remain free of disease progression after nine months. The goal is to see whether sorafenib can control this rare cancer when surgery is not an option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sorafenib, a drug that blocks enzymes tumors need to grow and cuts off their blood supply
What this could lead to
If it works, sorafenib could offer a way to slow or control angiosarcoma that surgeons cannot remove, giving patients more time without their disease worsening.
What could go wrong
This is a mid-stage trial in a rare cancer, so results may not hold up in larger studies. Sorafenib can cause side effects such as fatigue, skin reactions, high blood pressure, and liver problems, and not everyone will respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

88 people

The number who actually took part.

Started

May 2008

Finished

May 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU La Timone

    Marseille, 13385, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre François Baclesse

    Caen, 14076, France

  • Centre Georges François Leclerc

    Dijon, 21079, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    Lyon, 69008, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centre René Gauducheau

    Saint-Herblain, 44805, France

  • Centre Val d'Aurelle

    Montpellier, 34298, France

  • Groupe Hospitalier Cochin Cancer Ouest AP-HP

    Paris, 75619, France

  • Hôpital Jean Minjoz

    Besançon, 25503, France

  • Hôpital Saint-Louis

    Paris, 75010, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Claudius Regaud

    Toulouse, 31052, France

  • Institut Curie

    Paris, 75005, France

  • Institut Paoli-Calmettes

    Marseille, 13273, France

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42270, France

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