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Clinical trialNCT04200443Active, not recruitingPhase 2Interventional

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

SponsorCity of Hope Medical CenterEnrollment96Metastatic LeiomyosarcomaMetastatic Soft Tissue SarcomaStage III Uterine Corpus Leiomyosarcoma AJCC v8Stage IIIA Uterine Corpus Leiomyosarcoma AJCC v8Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8Stage IIIC Uterine Corpus Leiomyosarcoma AJCC v8+5 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • City of Hope Medical Center

    Duarte, California, United States

  • Northwestern University

    Chicago, Illinois, United States

  • University of Iowa/holden Comprehensive Cancer Center

    Iowa City, Iowa, United States

  • Washington University School of Medicine

    St Louis, Missouri, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
14 Jan 2020
Primary completion
4 Apr 2025
Completion
10 Sept 2026
Last update posted
1 May 2026
Registered enrollment
96
Registry id
NCT04200443

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.