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Tests treatment safety and results for Bone Sarcoma
Official title Efficacy of Regorafenib Combined With Best Supportive Care as Maintenance Treatment in High Grade Bone Sarcomas Patients
ClinicalTrials.gov ID: NCT04698785
What this study is testing
- What it's testing
- This is a multicenter phase II study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or at relapse. Patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion.
- Phase 2: a mid-size study of how well it works
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 high-grade sarcomas of bone primary localisation, including but not limited to: Osteosarcomas, Ewing...
- I3. Evaluable residual disease not amenable to resection after multimodal treatment principles either at diagnosis (after standard multimodal...
- I4. Non progressive disease (defined by the investigator according to the RECIST version 1.1 Appendix 1) at study entry;
- I5. Interval between the date of last anticancer treatment (chemotherapy or surgery) and the start date of regorafenib: at least 4 weeks but no...
You likely can't join if
- E1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to regorafenib, sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR...
- 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;
See the full eligibility criteria
Who can join
- I1. Age ≥ 12 years at the day of consenting to the study;
- I2. Patients must have histologically confirmed high-grade sarcomas of bone primary localisation, including but not limited to: Osteosarcomas, Ewing sarcomas, Chondrosarcomas, Undifferenciated Pleomorphic Sarcomas...
- I3. Evaluable residual disease not amenable to resection after multimodal treatment principles either at diagnosis (after standard multimodal treatment based on the histological subtype) or at relapse (chemotherapy)
- I4. Non progressive disease (defined by the investigator according to the RECIST version 1.1 Appendix 1) at study entry;
- I5. Interval between the date of last anticancer treatment (chemotherapy or surgery) and the start date of regorafenib: at least 4 weeks but no longer than 2 months;
- I6. Life expectancy of greater than 6 months;
- I7. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky ≥ 70%) (Appendix 2);
- I8. Adequate bone marrow and organ function defined by the following laboratory results:
- a. Bone marrow: i. Absolute neutrophil count ≥ 1.5 Giga/l ii. Platelets ≥ 100 Giga/l iii. Haemoglobin≥ 9 g/dl
- b. Hepatic function: i. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x Upper Limit of Normal (ULN) (≤ 5.0 × ULN for patients with liver involvement of their cancer) ii. Bilirubin ≤1.5 X ULN...
- c. Renal function: i. Serum creatinine ≤ 1.5 x ULN ii. Glomerular Filtration Rate (GFR) ≥ 30 ml/min/1.73m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula iii. Spot urine must not show ≥ 1 "+"...
- d. Coagulation: International Normalized Ratio (INR)/Partial Thromboplastin Time (PTT) ≤1.5 x ULN; Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate...
- e. Pancreatic function: Lipase ≤ 1.5 x ULN
- I9. Recovery to anticancer-treatment related NCI-CTCAE v5 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug/procedure related toxicity (except alopecia, anaemia, and...
- I10. Women of childbearing potential and male patients must agree to use adequate contraception (including at least the use of condoms) for the duration of treatment and for 7 months (210 days) in women of childbearing...
- I11. Patients, and their parents when applicable, must sign and date an informed consent document indicating that they have been informed of all the pertinent aspects of the trial prior to enrolment;
- I12. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures;
- I13. Patients affiliated to the Social Security System
- I14. Body Surface Area (BSA) ≥ 1.30m² at the time of consenting to the study
What rules you out
- E1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to regorafenib, sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor); E2. All soft tissue sarcomas (including but not limited to...
- 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;
- Uncontrolled hypertension (systolic blood pressure \> 150 mm Hg or diastolic pressure \> 90 mm Hg despite optimal treatment);
- 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 before the first study drug...
- 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; E10. 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
- Dijon, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Paris, France
- Saint-Herblain, France
- Saint-Priest-en-Jarez, France
- Strasbourg, France
- Toulouse, 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; Dijon, France; Lille, France; Lyon, France; Marseille, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.