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New hope for sarcoma patients: drug slows tumor growth in late-stage trial

NCT ID NCT01900743

Disease control Sponsor: Centre Oscar Lambret Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug regorafenib in 219 adults with soft tissue sarcoma that had spread and was no longer responding to standard chemotherapy. Participants were randomly assigned to receive either regorafenib or a placebo. The main goal was to see if the drug could delay cancer growth or improve survival. The trial was completed and results help doctors understand if this treatment offers a meaningful benefit for this difficult-to-treat cancer.

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

219 people

The number who actually took part.

Started

Jun 2013

Finished

Sep 2020

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 years and older

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.

Inclusion Criteria: * Age ≥18 years * Histological documentation of soft tissue sarcoma (including uterus)with available Formalin Fixed Paraffin Embedded (FFPE) blocks. Eligible soft tissue sarcomas are non-adipocytic soft tissue sarcomas * Prior treatment with doxorubicin or other anthracycline. Moreover, patients eligible in the Cohort E must have received pazopanib * Metastatic disease not amenable to surgical resection with curative intent * Documentation of progression within the last 6 months * Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST 1.1. * Performance status ≤1(ECOG) * Life expectancy ≤ 3 months * Adequate bone marrow, renal, and hepatic function: * INR/PTT ≤1.5 x ULN Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring will be performed until INR/PTT is stable. * Women of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy. * Recovery to NCI-CTCAE v4.0 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug/procedure related toxicity (except alopecia, anemia, and hypothyroidism). * In the assessment of the investigator, patient is able to comply with study requirements * Signed, IRB-approved written informed consent Exclusion Criteria: * More than 3 lines of systemic treatment for metastatic sarcoma * Histological subtypes listed in Appendix C (especially GIST, osseous sarcoma, embryonal or alveolar rhabdomyosarcoma). Patients with liposarcoma are not eligible in the cohort E * Primary bone sarcoma * Prior treatment with regorafenib * Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator * Pregnant or breastfeeding patients. Women of childbearing potential must have a pregnancy test performed before start of treatment * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of treatment * Active cardiac disease including any of the following: Congestive heart failure (NYHA) ≥Class 2, Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) * Uncontrolled hypertension (SBP \>150 mmHg or diastolic pressure \>90 mmHg despite optimal medical management) * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism (within the last 6 months) * Ongoing infection \>Grade 2 according to NCI-CTCAE v4.0 * Known history of human immunodeficiency virus (HIV) infection * Known history of chronic hepatitis B or C * Patients with seizure disorder requiring medication * History of organ allograft * Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event \> Grade 3 within 4 weeks of start of treatment * Non-healing wound, ulcer, or bone fracture * Renal failure requiring hemo- or peritoneal dialysis * Dehydration according to NCI-CTC v 4.0 Grade \>1 * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation, including lactose * Interstitial lung disease with ongoing signs and symptoms at the time of informed consent * Inability to swallow, malabsorption condition * Pleural effusion or ascites that causes respiratory compromise (Grade 2 dyspnea)

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis sarcoma soft tissue sarcoma

As listed by the trial registrant

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

Sarcoma

Contacts and locations

Locations

  • AKH-Wien

    Vienna, 1090, Austria

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54519, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Eugène Marquis

    Rennes, 35042, France

  • Centre François Baclesse

    Caen, 14076, France

  • Centre GF Leclercq

    Dijon, 21079, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Léon Bérard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centre René Gauducheau

    Nantes, 44805, France

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Saint Louis

    Paris, 75010, France

  • Hôpital St Jacques

    Besançon, 25000, France

  • Hôpital de La Timone

    Marseille, 13354, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Claudius Regaud

    Toulouse, 32052, France

  • Institut Curie

    Paris, 75005, France

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, 92210, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut de Cancérologie Lucien Neuwirth (ICL)

    Saint-Priest-en-Jarez, 42270, France

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, 4010, Austria

  • LKH

    Klagenfurt, Austria

  • Medizinische Universität Graz

    Graz, 8036, Austria

  • Universitätsklinik für Innere Medizin I

    Innsbruck, 6020, Austria

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