A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone S… (NCT02389244) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
France163 participantsStarted 2014-09
Plain-language summary
INDICATION:
Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas
Who can participate
Age range10 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients must have histologically confirmed diagnosis of bone sarcoma (osteosarcoma, Ewing sarcoma of bone, chondrosarcoma or chordoma);
✓. Patients with confirmed disease progression at study entry;
✓. Metastatic disease not amenable to surgical resection or radiation with curative intent;
✓. Patients must have measurable disease;
✓. Prior treatment :
✓. Age ≥10 years for osteosarcomas, Ewing sarcomas and chondrosarcomas (for chordomas, patients must be ≥18 years);
✓. Body Surface Area ≥1.30 m²;
✓. Life expectancy of greater than 3 months;
Exclusion criteria
✕. Prior treatment with any VEGFR inhibitor;
✕. Soft tissue sarcoma;
✕. Other cancer (different histology) within 5 years prior to randomization;
✕. Major surgical procedure, open biopsy, significant trauma, within the last 28 days before randomization;
✕. Cardiovascular dysfunction:
✕. 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 randomization;
What they're measuring
1
Non-progression rate
Timeframe: 8 weeks for cohorts A, B and E, 12 weeks for cohort C, 6 months for cohort D