Efficacy and safety of regorafenib in patients with metastatic bone sarcomas (REGOBONE)

This study evaluates the efficacy and safety of regorafenib in patients with metastatic bone sarcomas.

Trial name REGOBONE
Agents Regorafenib
Phase II
Status  Open, recruiting (France only)
Sponsor UNICANCER

A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas (REGOBONE)
Further information: https://www.clinicaltrials.gov/ct2/show/NCT02389244?term=regorafenib+sarcoma&rank=3

 

WHO is the trial for?
  • Patients must have histologically confirmed diagnosis of bone sarcoma (osteosarcoma, Ewing sarcoma of bone, chondrosarcoma or chordoma)
  • Patients with confirmed disease progression and metastatic disease not amenable to surgical resection or radiation with the intent to cure the disease
  • Patients must have at least one prior treatment, but no more than two prior chemotherapies for metastatic disease for osteosarcoma, chondrosarcoma and Ewing sarcoma. Previously untreated chordoma patients or chordoma patients with 1 or 2 prior chemotherapies or targeted therapies, but no more than 2 prior lines of treatment.
  • Overall health status of the patient has to be good (ECOG performance status < 2)
  • Adequate function of bone marrow, liver and kidneys and normal organ function

WHAT is the key question that this trial is attempting to answer?

 This study assesses the safety and efficacy of regorafenib in patients with metastatic bone sarcomas.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in bone sarcomas and potentially help other patients with these diseases. The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

  The study is open (recruiting)

WHERE is the trial available?

 The trial is available in several study centers in France.

For a complete list of trial locations, please see here.

Study contacts:

STUDY DESIGN: What does the study look like?

 There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Two thirds of the patients will be assigned to regorafenib, the other group (one third of the patients) will receive placebo.

The study has 4 cohorts: Ewing Sarcomas, Chondrosarcomas, Osteosarcomas and Chondromas.

Regorafenib will be given at a dose of 160mg once a day, 3 weeks on / 1 week off. Patients, who might progress on placebo can receive/cross-over to the regorafenib arm.

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.eu

SHARE your experience

 You want to share your experience on this trial?
Send us an e-mail to: info@sarcoma-patients.eu
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

 No results are available at this time. Future results will be linked here.

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken

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