Chordoma Trials in Disease

Study on the Effectiveness and Safety of Regorafenib for Patients with Metastatic Bone Sarcomas

This clinical trial is taking place in France and focuses on evaluating a medication called regorafenib in patients with metastatic bone sarcomas. The study includes patients with several types of bone cancers, including chordoma, osteosarcoma, Ewing sarcoma, CIC-rearranged sarcoma, and chondrosarcoma.

Main Inclusion Criteria:

• Patients must have a confirmed diagnosis of CIC-rearranged sarcoma affecting bone or soft tissue
• Patients must be at least 10 years old
• Patients must have measurable disease, meaning at least one tumor that can be accurately measured using a CT scan
• Patients must have disease progression, shown by recent scans demonstrating that the cancer has worsened
• Patients must have adequate bone marrow, kidney, and liver function based on blood and urine tests
• Patients must have a life expectancy of more than 3 months
• Patients must have had no more than three previous chemotherapy treatments
• The cancer must not be treatable with surgery or radiation that could cure the disease
• Patients must have a body surface area of at least 1.30 square meters
• Patients must have a performance status that demonstrates they can carry out daily activities, measured on specific scales

Main Exclusion Criteria:

• Patients with a different type of cancer than bone sarcoma cannot participate
• Patients who are pregnant or breastfeeding are not eligible
• Patients currently participating in another clinical trial cannot join this study
• Patients with other serious health conditions that might interfere with the study are excluded
• Patients who have had certain recent treatments or medications that might affect the study cannot participate
• Patients who are unable to follow study procedures or instructions are not eligible

Focus and Goal:

The main focus of this trial is to evaluate how well regorafenib works in controlling metastatic bone sarcomas and to assess its safety for patients. Participants will receive either regorafenib or a placebo (an inactive substance). Throughout the study, which is expected to continue until September 2026, patients will be monitored regularly through imaging tests such as MRI or CT scans to track how the cancer responds to treatment. The study aims to measure the non-progression rate at specific time points, as well as progression-free survival and overall survival. Researchers will closely observe patients for any side effects or changes in their condition to understand the potential benefits and risks of using regorafenib for treating this type of cancer.

Investigational Drug:

The medication being tested is regorafenib, which is given as oral tablets (40 mg film-coated tablets). Regorafenib is a multikinase inhibitor, meaning it works at the molecular level by blocking multiple protein kinases that are involved in tumor growth and the development of blood vessels that supply the tumor. The study will determine the appropriate dosage and frequency according to the study protocol, while monitoring patients for side effects.

Summary

Currently, there is one clinical trial available for patients with chordoma, located in France. This trial is part of a broader study examining regorafenib's effectiveness in treating various types of metastatic bone sarcomas. The trial focuses on patients whose cancer has progressed and cannot be cured through surgery or radiation. The study employs a rigorous approach with regular monitoring through imaging tests and laboratory assessments to evaluate both the effectiveness and safety of regorafenib. Patients interested in participating should note the specific eligibility requirements, including age restrictions, disease status, and previous treatment history.