NCT06156410

Cabozantinib With Ifosfamide in Relapsed/Refractory Sarcomas

A Phase I Trial of Cabozantinib (XL184) in Combination With High-dose Ifosfamide in Adults and Children With Relapsed/Refractory Sarcomas (CaIRS Trial)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 5 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to better understand how safe and effective the drug cabozantinib in combination with high-dose ifosfamide is in the treatment of children and adults with relapsed/refractory sarcomas.

Detailed description

In this study, the investigators will test the activity of cabozantinib in combination with high-dose ifosfamide as targeted therapy for relapsed/refractory sarcomas. Cabozantinib has been shown to inhibit multiple tyrosine kinases, including potent inhibition of kinases, MET and VEGFR2. Therefore, the goal of this study is to see if Cabozantinib can be used to inhibit MET and VEGFR2, or other tyrosine kinases to drive tumor responses in patients.

Conditions

• Ewing Sarcoma
• Osteosarcoma
• Sarcomas

Interventions

Type	Name	Description
DRUG	Cabozantinib	Participants will receive cabozantinib in combination with high-dose ifosfamide for 5 cycles. If still on study therapy the participants will continue with cabozantinib monotherapy for up to 12 total cycles.

Timeline

• Start date: 2023-10-24
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2023-12-05
• Last updated: 2025-11-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study