Clinical Trials Directory

Trials / Terminated

TerminatedNCT04220229

Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities

A Phase 1/2 Study of Neoadjuvant Cabozantinib in Combination With Radiation Therapy for Sarcomas of the Extremities

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
6 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I/II trial studies the side effects and best dose of cabozantinib when given with radiation therapy and how well it works in treating patients with sarcoma of the extremities. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cabozantinib with radiation therapy may make the tumors smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description

OUTLINE: This is a phase I, dose-escalation study of cabozantinib followed by a phase II, dose-expansion study. Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning Cycle 1 Day 8, patients also undergo standard of care radiation therapy for 5-6 weeks. After completion of study treatment, patients are followed up at 30 days, every 12 weeks for up to 1 year, then every 6 months for up to 3 years.

Conditions

Interventions

TypeNameDescription
DRUGCabozantinib S-malateGiven PO
RADIATIONRadiation TherapyUndergo standard of care radiation therapy

Timeline

Start date
2020-06-01
Primary completion
2024-04-05
Completion
2024-10-31
First posted
2020-01-07
Last updated
2025-07-17
Results posted
2025-07-17

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04220229. Inclusion in this directory is not an endorsement.