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Phase Ib / Regorafenib With Conventional Chemotherapy/Newly Diagnosed Patients/ Multimetastatic Ewing Sarcoma

NCT05830084 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-01-06

No results posted yet for this study

Summary

New drug efficacy in ES has been disappointing in the last decades and no new drugs have been successfully introduced up to now in front line treatment. Among the tested drugs, early clinical data suggest that strategies using multi-targeted tyrosine kinase inhibitors (TKI) with anti-angiogenic activities are among the most efficient and may be beneficial in the treatment of patients with ES.

Several TKI have been and are currently being tested as single-agent in patients with relapsed/refractory ES with encouraging results in phase II trials. Regorafenib has shown promising activity in Ewing sarcoma relapse setting, Nevertheless, regorafenib has never been combined with the intensive chemotherapy VDC/IE schedule and therefore this combination needs to be evaluated in order to avoid dose reduction of the current standard treatment and hence its efficacy.

The current clinical trial has been therefore designed to test the feasibility of regorafenib with ES conventional chemotherapy. It consists of a phase Ib that will only recruit patients with multi-metastatic (other than lungs/pleura only) ES, that present the highest unmet medical need (2 year EFS: 33%, similar to patients with relapse/refractory ES).

Conditions

  • Ewing Sarcoma

Interventions

DRUG

regorafenib tablet

Regorafenib will be escalated/de-escalated, starting at DL0: * DL1: 82 mg/m\^2 once daily for 21 days/28 days (max 160mg) (100% of the RP2D) * DL0 (starting dose): 66 mg/m\^2 once daily for 21 days/28 days (max 120mg) (80% of the RP2D) * DL-1: 50 mg/m\^2 once daily for 21 days/28 days (max 80mg) (60% of the RP2D)

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Pablo Berlanga, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2027-04-30
Completion
2027-10-31

Countries

  • Australia
  • Denmark
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05830084 on ClinicalTrials.gov