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Small Molecule Oral Kinase Inhibitor

Cohort C: Ewing sarcoma for Rhabdomyosarcoma

Phase 2
Waitlist Available
Led By Robert Maki, MD, PhD
Research Sponsored by Sarcoma Alliance for Research through Collaboration
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing if the drug regorafenib can help treat patients with different kinds of sarcomas who have tried other treatments.

Eligible Conditions
  • Rhabdomyosarcoma
  • Osteosarcoma
  • Ewing Sarcoma
  • Chondrosarcoma
  • Liposarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS). Cohort A and Cohort B
Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E
Secondary outcome measures
Disease Specific Survival (DSS). Cohorts A and B, After Crossover.
Overall Response Rate (ORR). All Cohorts.
Overall Survival (OS). Cohorts A and B, After Crossover.
+4 more

Trial Design

7Treatment groups
Active Control
Placebo Group
Group I: Cohort C: Ewing sarcomaActive Control1 Intervention
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Group II: Cohort E: Mesenchymal ChondrosarcomaActive Control1 Intervention
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Group III: Cohort A: LiposarcomaActive Control1 Intervention
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Group IV: Cohort B: OsteosarcomaActive Control1 Intervention
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Group V: Cohort D: RhabdomyosarcomaActive Control1 Intervention
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib
Group VI: Cohort A: Liposarcoma, PlaceboPlacebo Group1 Intervention
21 days on and 7 days off Placebo
Group VII: Cohort B: Osteosarcoma, placeboPlacebo Group1 Intervention
21 days on and 7 days off Placebo

Find a Location

Who is running the clinical trial?

Sarcoma Alliance for Research through CollaborationLead Sponsor
25 Previous Clinical Trials
1,823 Total Patients Enrolled
1 Trials studying Rhabdomyosarcoma
366 Patients Enrolled for Rhabdomyosarcoma
Robert Maki, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
7 Previous Clinical Trials
255 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Expert Opinion on Emerging DrugsJournal
An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?
Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.
clinicaltrials.govStudy
SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes
2014. "SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02048371.
~12 spots leftby Apr 2025
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