MedTrace Logo

Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma

NCT04200443 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-05-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Metastatic Leiomyosarcoma
  • Metastatic Soft Tissue Sarcoma
  • Stage III Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IIIA Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IIIC Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IV Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IVA Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IVB Uterine Corpus Leiomyosarcoma AJCC v8
  • Unresectable Leiomyosarcoma
  • Unresectable Soft Tissue Sarcoma

Interventions

DRUG

Cabozantinib

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Janet Yoon, MD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2025-04-04
Completion
2026-09-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04200443 on ClinicalTrials.gov