CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 96 enrolled
Drug / intervention
Cabozantinib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04200443
NCT04200443Phase 2Active

A Phase II Study of Cabozantinib and Temozolomide in Patients With Unresectable or Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas

City of Hope Medical Center·interventional·Posted Dec 16, 2019·Updated May 1, 2026

In Brief

A Phase 2 clinical trial evaluating Cabozantinib, Quality-of-Life Assessment, and 2 other interventions for Metastatic Leiomyosarcoma and 10 related conditions. Active but no longer recruiting, targeting 96 participants across 5 sites.

Detailed Summary

This phase II trial studies how well cabozantinib and temozolomide work in treating patients with leiomyosarcoma or other soft tissue sarcoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cabozantinib and temozolomide may work better than either one alone in treating patients with leiomyosarcoma or other soft tissue sarcoma. Cabozantinib is an investigational drug, which means that it has not been approved by the United States (US) Food and Drug Administration (FDA) or any other regulatory agencies for sale or use by the public for the indication under investigation in this study.

Study Details

Timeline

Phase 2Active
2020202120222023202420252026
First PostedDec 16, 2019
Enrollment StartJan 14, 2020
Primary CompletionApr 4, 2025
Study CompletionSep 10, 2026
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 6.5 years ago

Interventions

Cabozantinibdrug

Given PO

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Temozolomidedrug

Given PO