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Tests treatment safety and results for Bone Sarcoma
Official title Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas
ClinicalTrials.gov ID: NCT04055220
What this study is testing
What is Treatment by Regorafenib?
Treatment by Regorafenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bone sarcoma.
Also referred to as Stivarga.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Randomized, non-comparative, multicentre exploratory phase II study. Two arms concerning patients with bone sarcoma after the first line therapy: in the first arm, patients will be treated with Regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be kept under surveillance (standard of care).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- I1. Age ≥ 12 years at the day of consenting to the study; I2. Patients must have histologically confirmed diagnosis of primary bone sarcoma including...
- At least one lung nodule of 10mm or more
- And/or at least two nodules well limited between 6-9mm
- And/or at least 5 nodules well limited of 5mm or less All the other situations will be considered as doubtful lesions except in case of metastatic...
- Absolute neutrophil count ≥ 1.5 Giga/l
See the full eligibility criteria
- I1. Age ≥ 12 years at the day of consenting to the study; I2. Patients must have histologically confirmed diagnosis of primary bone sarcoma including but not limited to: Osteosarcomas, Ewing sarcomas, Chondrosarcomas...
- At least one lung nodule of 10mm or more
- And/or at least two nodules well limited between 6-9mm
- And/or at least 5 nodules well limited of 5mm or less All the other situations will be considered as doubtful lesions except in case of metastatic disease confirmed during the lung surgery of the residual lung lesions...
- Absolute neutrophil count ≥ 1.5 Giga/l
- Platelets ≥ 100 Giga/l
- Haemoglobin≥ 9 g/dl
- Serum creatinine ≤ 1.5 x ULN
- Glomerular filtration rate (GFR) ≥30 ml/min/1.73m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula
- 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 in patient with liver involvement of their cancer). If Alkaline phosphatase \> 2.5 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes...
- Lipase ≤1.5 x ULN
- Spot urine must not show ≥ 1 "+"protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1 "+" protein or more, a 24-hour urine collection will be required and must show total...
- Left ventricular ejection fraction (LVEF) \< 50%,
- Congestive heart failure ≥ New York Heart Association (NYHA) class 2,
- Myocardial infarction \< 6 months prior to first study drug administration,
- Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted),
- Unstable (angina symptoms at rest) or new-onset angina within the last 3 months prior to first study drug administration; E5. Uncontrolled hypertension (systolic blood pressure \> 150mmHg or diastolic pressure \> 90...
- No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months prior to enrolment;
- No history of AIDS-defining cancers (e.g. Kaposi's sarcoma, aggressive B-cell lymphoma and invasive cervical cancer);
- people should be on established anti-retroviral therapy for at least 4 weeks and have an HIV viral load of \ 1; E12. Difficulties to swallow oral medication and/or any mal-absorption condition and/or any...
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Paris, France
- Poitiers, France
- Saint-Etienne, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Lille, France; Lyon, France; Marseille, France; Montpellier, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.