Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2019-05-15
2024-09-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
Regorafenib
Regorafenib
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
Arm B
Placebo
Placebo
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Regorafenib
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
Placebo
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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
Exclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Oscar Lambret
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicolas PENEL, PhD
Role: STUDY_DIRECTOR
Centre Oscar Lambret
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHRU Besançon
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre François Baclesse
Caen, , France
Centre Georges-François LECLERC
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Hôpital La Timone
Marseille, , France
Institut Paoli-Calmettes
Marseille, , France
Institut régional du Cancer de Montpellier
Montpellier, , France
Centre René Gauducheau
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Institut Curie
Paris, , France
Chu Poitiers
Poitiers, , France
Institut Godinot
Reims, , France
Centre Eugène Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Hôpitaux universitaires de Strasbourg
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EREMISS
Identifier Type: -
Identifier Source: org_study_id