study evaluating the efficacy of regorafenib as maintenance treatment in patients with high grade bone sarcomas (HGBS) at diagnosis or relapse and without complete remission after standard treatment

Phase 1

• Conditions: Patients with high grade bone sarcomas (HGBS) at diagnosis or first relapse and without complete remission after standard treatment; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002629-31-FR
• Lead Sponsor: Centre Léon Bérard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-23
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

I1. Age = 16 years at the day of consenting to the study ;
I2. Patients must have histologically confirmed high-grade bone sarcomas of one of the following histotypes:
• Osteosarcomas (conventional-intramedullary/central high grade, small cell, telangiectatic or high-grade surface osteosarcomas) ;
• Bone sarcomas other than Ewing sarcoma, chondrosarcoma and chordoma ;
I3. Measurable residual disease after multimodal treatment principles either at diagnosis (after surgery and pre and/or post-surgery chemotherapy) or at first 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 date of randomization : at least 4 weeks but no longer than 2 months ;
...See the protocol
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

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 soft tissue osteosarcoma), and Ewing sarcoma, chondrosarcoma and chordoma ;
E3. Prior history of malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within 3 years prior to randomization ;
E4. Cardiovascular dysfunction defined by:
• 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 > 150mmHg or diastolic pressure > 90 mmHg 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 administration ;
E5. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before the first study drug administration ;
...See the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified