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Metastatic Soft Tissue SarcomaPhase 2EREMISSNCT03793361

Phase II Study of Regorafenib as Maintenance Therapy

A Phase 2 study testing Regorafenib in people with Metastatic Soft Tissue Sarcoma, run by Centre Oscar Lambret at 20 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

Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Soft Tissue Sarcoma
What is being tested?
Regorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
127 participants
Where
20 sitesFrance
Study dates
15 May 2019to 26 Sep 2024
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
  • Histologically proven soft tissue sarcoma including leiomyosarcoma, synovial sarcoma and other sarcomas
  • Patients in partial response or stable disease after 6 cycles of doxorubicin-based first-line chemotherapy for metastatic/locally advanced soft tissue sarcoma
  • Metastatic/locally advanced disease not amenable to surgical resection with curative intent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status =0 or 1
  • Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST 1.1.
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  • Available tumor tissue for translational research program
  • Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:
  • Absolute neutrophil count (ANC) ≥1,500/mm3
  • Platelets ≥100,000/mm3
  • Hemoglobin ≥9.0 g/dL
  • Serum creatinine ≤1.5 x upper limit of normal (ULN)
  • Glomerular filtration rate (GFR) ≥30 ml/min/1.73m2
  • AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer)
  • Bilirubin ≤1.5 X ULN
  • Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)
  • Lipase ≤1.5 x ULN
  • Spot urine must not show 1+ or more protein in urine or the patient will require a repeat urine analysis. If repeat urinanalysis shows 1+ protein or more, a 24-hour urine collection will be required and must show total protein excretion <1000 mg/24 hours
  • 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 of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care.)
  • Women of childbearing potential and male subjects must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care.
  • Recovery to National Cancer Institute-Common Terminology Criteria for Adverse Events (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, patients are able to comply with study requirements
  • Signed, IRB-approved written informed consent
  • Patient covered by the French "Social Security" regime

Who cannot join

  • Prior adjuvant or neoadjuvant chemotherapy not allowing at least 6 cycles of doxorubicin-based chemotherapy at metastatic stage
  • Complete response to 1st line chemotherapy for metastatic/locally advanced soft tissue sarcoma
  • Disease progression during the 1st line of chemotherapy
  • Time interval between the last cycle of doxorubicin-based chemotherapy superior to 8 weeks
  • Primary bone sarcoma
  • All forms of liposarcoma
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  • Some particular histologic types, i.e., PNET/Ewing, alveolar or embryonal rhabdomyosarcoma, Perivascular epithelioid cell sarcoma (PECoMA), low grade endometrial stromal tumor, desmoid tumor
  • Prior treatment with tyrosine kinase inhibitor
  • 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 a maximum of 7 days before start of treatment
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of Day 1 of treatment
  • Active cardiac disease including any of the following: Congestive heart failure (New York Heart Association [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 (Systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg despite optimal medical management)
  • Arterial or venous thrombotic or embolic events such as myocardial infarction, cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months of starting on study drug
  • Any hemorrhage or bleeding event > Grade 4 within 4 weeks of start of treatment
  • Ongoing infection >Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v. 5.0)
  • 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 4 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
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
  • Inability to swallow oral medications, Any mal-absorption condition
  • Pleural effusion or ascites that causes respiratory compromise (Grade 2 dyspnea)

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • CHRU Besançon

    Besançon, 25000

  • Institut Bergonié

    Bordeaux, 33076

  • Centre François Baclesse

    Caen, 14076

  • Centre Georges-François LECLERC

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital La Timone

    Marseille, 13005

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Institut régional du Cancer de Montpellier

    Montpellier, 34298

  • Centre René Gauducheau

    Nantes, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie

    Paris, 75005

  • Chu Poitiers

    Poitiers, 86000

  • Institut Godinot

    Reims, 51100

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42270

  • Hôpitaux universitaires de Strasbourg

    Strasbourg, 67000

  • Institut Claudius Regaud

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Efficacy of Regorafenib as Maintenance Therapy in Non-adipocytic Soft Tissue Sarcoma Having Received First-line Doxorubicin-based Chemotherapy

Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy.

Read the detailed description

Patients will be randomized 1:1 using a centralized randomization software, assuring concealment, with a minimization program controlling for the following factors:

  • Histological subgroups: leiomyosarcoma versus synovial sarcoma versus other histological subtype
  • Response to doxorubicin-based chemotherapy: partial response versus stable disease
  • Centers

The treatment will be administrated as long as it appears beneficial. Evaluations will be made every 8 weeks until 6 months and then every 3 months

Being tested
Regorafenib, Placebo
Medical subject headings
Sarcoma

What participants receive

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

  • RegorafenibDrug

    Also called stivarga

    Oral Drug in the form of 40 mg tablets - Regorafenib (120 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.

    Provided by BAYER

  • PlaceboDrug

    Oral tablets - 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

    Provided by BAYER

Study groups in NCT03793361
Study groupRoleWhat they receive
Arm AExperimentalRegorafenib
Receives: Drug: Regorafenib
Arm BPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. To assess the efficacy of regorafenib compared to placebo

    Progression-Free Survival will be measured from the date of randomization until the date of radiological progression (according to RECIST 1.1 criteria) or death (if death occurs before progression).

    Measured: from the date of randomization to the date of first observed disease progression (according to RECIST 1.1 criteria) or death from any cause, up to 12 months after the beginning of the treatment

Secondary outcomes (5)

  1. To assess the efficacy of regorafenib compared to placebo

    in terms of overall survival

    Measured: from the date of randomization to the date of death from any cause

  2. To assess the efficacy of regorafenib compared to placebo

    Best response according to RECIST 1.1 evaluated by central radiological review: Complete Response, CR, or Partial Response, PR, achieved during the maintenance therapy. CR and PR will be counted as objective response to estimate the objective response rate (ORR)

    Measured: from the date of randomization to the date of first observed disease progression (according to RECIST 1.1) or death from any cause, up to 12 months after the beginning of the treatment

  3. To assess the efficacy of regorafenib compared to placebo

    Time to start subsequent line of anticancer therapy defined as the time interval from the date of randomization to the date of start subsequent line of anticancer therapy. Patient data will be censored at the date of last follow-up visit for patients alive at last follow-up visit without having started subsequent line of anticancer therapy. Death without having started subsequent line of anticancer therapy will be counted as a competing event.

    Measured: from the date of randomization to the date of death from any cause, up to 12 months after the beginning of the treatment

  4. To assess the safety of regorafenib

    Compared to placebo - Toxicity according to NCI-CTC AE V5.0 over the whole treatment duration plus 30 days, excluding AE unequivocally related to the disease under study or its progression. Adverse events of grade 3 or more (grade 3+) will be counted as severe adverse events

    Measured: Baseline, every 4 weeks, up to 12 months after the beginning of the treatment

  5. To assess the relative benefit/risk ratio

    using the Q-TWiST approach - Quality-adjusted time without symptoms of disease or toxicity computed from survival times (overall survival and progression-free survival) and adverse events data (date of occurrence of grade 3+ adverse event classified as drug-related)

    Measured: up to 12 months

Timeline

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

  1. First posted4 Jan 2019
  2. Study start15 May 2019
  3. Primary completion15 Mar 2024
  4. Study completion26 Sep 2024

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
Double blind
Who is masked
Participant, Investigator
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03793361
Sponsor's protocol ID
EREMISS-1801
Other IDs
PHRC-K18-158, 2018-001574-22, 2018
Acronym
EREMISS
Status last verified
Jun 2024
First submitted
28 Dec 2018
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib in people with Metastatic Soft Tissue Sarcoma, run by Centre Oscar Lambret at 20 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?

The sponsor lists 24 inclusion and 29 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 18 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 20 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. 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?

To assess the efficacy of regorafenib compared to placebo (time frame: from the date of randomization to the date of first observed disease progression (according to RECIST 1.1 criteria) or death from any cause, up to 12 months after the beginning of the treatment). 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 NCT03793361.

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 18 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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