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SarcomaPhase 2REGO-SARCNCT01900743

Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma

A Phase 2 study testing Regorafenib in people with Sarcoma, run by Centre Oscar Lambret at 25 sites in 2 countries.

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

This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
Regorafenib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
219 participants
Where
25 sitesin 2 countries
Study dates
5 Jun 2013to 16 Sep 2020
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

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

France20 sites

  • Hôpital St Jacques

    Besançon, 25000

  • Institut Bergonié

    Bordeaux, 33076

  • Centre François Baclesse

    Caen, 14076

  • Centre GF Leclercq

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hôpital de La Timone

    Marseille, 13354

  • Centre René Gauducheau

    Nantes, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie

    Paris, 75005

  • Hôpital Saint Louis

    Paris, 75010

  • Hôpital Cochin

    Paris, 75014

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, 92210

  • Institut de Cancérologie Lucien Neuwirth (ICL)

    Saint-Priest-en-Jarez, 42270

  • Institut Claudius Regaud

    Toulouse, 32052

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54519

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Austria5 sites

  • Medizinische Universität Graz

    Graz, 8036

  • Universitätsklinik für Innere Medizin I

    Innsbruck, 6020

  • LKH

    Klagenfurt

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, 4010

  • AKH-Wien

    Vienna, 1090

Other trials in Austria

About this study

Official title: Activity and Safety of Regorafenib in Patients With Metastatic Soft Tissue Sarcoma Previously Treated With Anthracycline-based Chemotherapy : a Multinational, Randomized, Phase II, Placebo-controlled Trial

This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline).

Five cohorts will be defined:

Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups.

Read the detailed description

The standard of care for metastatic soft tissue sarcoma is doxorubicin +/- ifosfamide. After failure or intolerance to doxorubicin, there is no standard of care. In Europe, two are currently approved for the treatment of soft tissue sarcoma after failure/intolerance to doxorubicin: trabectedin (Yondelis®) for all histological subtype and pazopanib (Votrient ®) for all subtypes excluding liposarcomas. Nevertheless, none of these drugs improve the overall survival over placebo.

The study is composed of 3 periods:

  1. A Screening Period,
  2. A Treatment Period,
  3. And a Survival Follow-up Period. Patients randomized to be treated with regorafenib will receive the treatment orally for 3 weeks of every 4 week (28 days) cycle (ie, 3 weeks on/1 week off).

Patients randomized to the placebo arm will be treated for 3 weeks of every 4 weeks cycle (ie, 3 weeks on/1 week off).

In addition to the regorafenib and placebo treatments, patients will receive best supportive care. Best supportive care includes any method to preserve the comfort and dignity of the patients and excludes any disease-specific anti-neoplastic therapy such as any kinase inhibitor,chemotherapy, radiation therapy, or surgical intervention.

Patients receiving placebo, who experience disease progression may be offered open-label regorafenib(cross-over option).

Conditions
Sarcoma
Being tested
Regorafenib, Placebo
Keywords
Sarcoma, Metastatic, Regorafenib
Medical subject headings
Sarcoma, Neoplasm Metastasis

What participants receive

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

  • RegorafenibDrug

    Also called stivarga

    Regorafenib (160 mg/d) once daily for three weeks on / one week off plus Best Supportive Care (BSC)until progression (according to RECIST 1.1), intolerance or consent withdrawal.

  • PlaceboDrug

    Placebo plus BSC until progression (according to RECIST 1.1) or unacceptable toxicity. Patients who have received placebo may be offered open-label regorafenib (cross-over option) after objective tumor progression

Study groups in NCT01900743
Study groupRoleWhat they receive
Arm AExperimentalRegorafenib (160 mg/d) once daily for 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or consent withdrawal.
Receives: Drug: Regorafenib
Arm BPlacebo comparatorPlacebo plus BSC until progression (according to RECIST 1.1) or unacceptable toxicity. Patients who have received placebo may be offered open-label regorafenib (cross-over option) after objective tumor progression
Receives: Drug: Placebo

What is being measured

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

  1. Progression-free survival (PFS)

    Progression-Free Survival will be measured from the date of randomization until the date of radiological progression or death (if death occurs before progression).

    Progression-free rate at 3 and 6 months (PFR-3 and PFR-6), time to progression, response rate and duration of response, overall survival according to RECIST 1.1 criteria

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Growth modulation index

    Growth modulation index in patients receiving regorafenib after randomization

    Measured: Up to 2 years

  2. Toxicity according to NCI-CTC AE V4.0.

    The monitoring of the toxicity of the regorafenib which can have a liver toxicity for exemple.

    Measured: Baseline, every 4 weeks, up to the end of study

  3. Progression-free rate at 3 and 6 months (PFR-3 and PFR-6)

    According to the RECIST 1.1

    Measured: At month 3 and at month 6

  4. Time to progression

    According to the RECIST 1.1 Every 4 weeks, Up to 2 years

    Measured: Up to 2 years

  5. Overall survival

    Time from the date of randomization to the date of death from any cause

    Measured: Up to 2 years

  6. Response rate

    the proportion of patients with the best overall tumor response of partial response (PR) or complete response (CR) according to RECIST 1.1 guidelines that is achieved during treatment or within 30 days after termination of study medication.

    Measured: Up to 2 years

  7. Duration of response

    the number of days from the date of first documented objective response of PR or CR, whichever is noted earlier, to first disease progression or death before progression. Patients without progression or death before progression at the time of analysis will be censored at the date of their last tumor assessment.

    Measured: Up to 2 years

Timeline

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

  1. First posted16 Jul 2013 (estimated)
  2. Study start5 Jun 2013
  3. Primary completion16 Sep 2020
  4. Study completion16 Sep 2020

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01900743
Sponsor's protocol ID
REGO-SARC-1214
Other IDs
2012-005743-24
Acronym
REGO-SARC
Status last verified
Mar 2026
First submitted
9 Jul 2013
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Penel N, Mir O, Wallet J, Ray-Coquard I, Le Cesne A, Italiano A, Salas S, Delcambre C, Bompas E, Bertucci F, Saada-Bouzid E, Chaigneau L, Chevreau C, Brodowicz T, Decoupigny E, Vanseymortier M, Laroche L, Taieb S, Le Deley MC, Blay JY. A double-blind placebo-controlled randomized phase II trial assessing the activity and safety of regorafenib in non-adipocytic sarcoma patients previously treated with both chemotherapy and pazopanib. Eur J Cancer. 2020 Feb;126:45-55. doi: 10.1016/j.ejca.2019.12.001. Epub 2020 Jan 6.

    PubMed 31918233

  • Longue M, Cabarrou B, Wallet J, Brodowicz T, Roche H, Boher JM, Delord JP, Penel N, Filleron T. The importance of jointly analyzing treatment administration and toxicity associated with targeted therapies: a case study of regorafenib in soft tissue sarcoma patients. Ann Oncol. 2018 Jul 1;29(7):1588-1593. doi: 10.1093/annonc/mdy168.

    PubMed 29722789

  • Berry V, Basson L, Bogart E, Mir O, Blay JY, Italiano A, Bertucci F, Chevreau C, Clisant-Delaine S, Liegl-Antzager B, Tresch-Bruneel E, Wallet J, Taieb S, Decoupigny E, Le Cesne A, Brodowicz T, Penel N. REGOSARC: Regorafenib versus placebo in doxorubicin-refractory soft-tissue sarcoma-A quality-adjusted time without symptoms of progression or toxicity analysis. Cancer. 2017 Jun 15;123(12):2294-2302. doi: 10.1002/cncr.30661. Epub 2017 Mar 10.

    PubMed 28295221

  • Mir O, Brodowicz T, Italiano A, Wallet J, Blay JY, Bertucci F, Chevreau C, Piperno-Neumann S, Bompas E, Salas S, Perrin C, Delcambre C, Liegl-Atzwanger B, Toulmonde M, Dumont S, Ray-Coquard I, Clisant S, Taieb S, Guillemet C, Rios M, Collard O, Bozec L, Cupissol D, Saada-Bouzid E, Lemaignan C, Eisterer W, Isambert N, Chaigneau L, Cesne AL, Penel N. Safety and efficacy of regorafenib in patients with advanced soft tissue sarcoma (REGOSARC): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Dec;17(12):1732-1742. doi: 10.1016/S1470-2045(16)30507-1. Epub 2016 Oct 14.

    PubMed 27751846

  • Brodowicz T, Liegl-Atzwager B, Tresch E, Taieb S, Kramar A, Gruenwald V, Vanseymortier M, Clisant S, Blay JY, Le Cesne A, Penel N. Study protocol of REGOSARC trial: activity and safety of regorafenib in advanced soft tissue sarcoma: a multinational, randomized, placebo-controlled, phase II trial. BMC Cancer. 2015 Mar 14;15:127. doi: 10.1186/s12885-015-1143-y.

    PubMed 25884155

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib in people with Sarcoma, run by Centre Oscar Lambret at 25 sites in 2 countries.

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 14 inclusion and 24 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France, Austria. 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. Some participants in this study may receive a placebo. 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 (PFS) (time frame: Up to 2 years). 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 NCT01900743, which also lists 5 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 13 Mar 2026.

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