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NCT04200443 · ClinicalTrials.gov registry record · Phase 2
Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma
A Phase 2 study of Metastatic Soft Tissue Sarcoma and Metastatic Leiomyosarcoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 5
- Study locations
NCT04200443: Active Phase 2 study of Metastatic Soft Tissue Sarcoma and Metastatic Leiomyosarcoma, sponsored by City of Hope Medical Center.
NCT04200443 is a Phase 2 study of Metastatic Soft Tissue Sarcoma and Metastatic Leiomyosarcoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 72 participants, below the 134-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (46% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04200443, a Phase 2 study of Metastatic Soft Tissue Sarcoma and Metastatic Leiomyosarcoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 criteria, for target lesions, progression is defined as at least a 20% increase in the sum of the longest diameter or the appearance of one or more new lesions; For non-target lesions, progression is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS will be the time from the start of treatment
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Temozolomide
- DRUG Cabozantinib
Study Locations (5)
California
- City of Hope Medical Center - Duarte
Illinois
- Northwestern University - Chicago
Iowa
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
Missouri
- Washington University School of Medicine - St Louis
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2026-09-10 |
| Phase | Phase 2 |
What the registry record for NCT04200443 still lists
NCT04200443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 134-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (46% lower).
The record links to 10 conditions, with Metastatic Soft Tissue Sarcoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04200443 lists 5 locations in 5 states (California, Illinois, Iowa).
Frequently Asked Questions
What is clinical trial NCT04200443 about?
NCT04200443 is a clinical study titled "Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma". 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 bl...
What is the current status of trial NCT04200443?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2020-01-14. Estimated completion is 2026-09-10.
What conditions does trial NCT04200443 study?
This clinical trial studies the following conditions: Metastatic Soft Tissue Sarcoma, Metastatic Leiomyosarcoma, Unresectable Leiomyosarcoma, Stage III Uterine Corpus Leiomyosarcoma AJCC v8, Stage IV Uterine Corpus Leiomyosarcoma AJCC v8.
What interventions are being tested in trial NCT04200443?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Temozolomide (DRUG), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT04200443?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04200443 being conducted?
This trial has 5 study locations across California, Illinois, Iowa, Missouri, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04200443's enrollment target sits among peer trials
72 8th of 12 higher than 5 of 12 other Metastatic Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Soft Tissue Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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