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NCT01782313 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas
A Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Stage IV Adult Soft Tissue Sarcoma, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 5
- Study locations
NCT01782313: Completed Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Stage IV Adult Soft Tissue Sarcoma, sponsored by Northwestern University.
NCT01782313 is a Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Stage IV Adult Soft Tissue Sarcoma that has completed, run by Northwestern University. The registered enrollment target is 58 participants, below the 83-participant average among 11 other Recurrent Adult Soft Tissue Sarcoma trials with a reported enrollment target (30% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01782313, a Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Stage IV Adult Soft Tissue Sarcoma, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study is for patients who have been diagnosed with soft tissue sarcoma that has spread (metastasized) or that is not eligible for removal by surgery. The purpose of this study is to determine how soft tissue sarcomas respond to treatment with an investigational drug called tivozanib. In some lab and clinical studies, tivozanib has been shown to interfere with the growth of some types of tumors. The study will also evaluate how safe the study treatment is by observing how many and what kind of adverse events (side effects) participants experience.
Primary Outcome
Progression-free survival from study disease will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Committee, version 1.1 assessed using imaging scans (CT or MRI) and clinical assessment following 16 weeks of treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", o
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG tivozanib
Study Locations (5)
Illinois
- Northwestern University - Chicago
Iowa
- University of Iowa - Iowa City
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University - St Louis
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2013-03-06 |
| Est. Completion | 2016-12-28 |
| Phase | Phase 2 |
What the finished NCT01782313 record still lists
NCT01782313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 83-participant average among 11 other Recurrent Adult Soft Tissue Sarcoma trials with a reported enrollment target (30% lower).
The record links to 3 conditions, with Recurrent Adult Soft Tissue Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT01782313 lists 5 locations in 5 states (Illinois, Iowa, Minnesota).
Frequently Asked Questions
What is clinical trial NCT01782313 about?
NCT01782313 is a clinical study titled "A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas". This study is for patients who have been diagnosed with soft tissue sarcoma that has spread (metastasized) or that is not eligible for removal by surgery. The purpose of this study is to determine how soft tissue sarcomas respond to treatment with an investigational drug called tivozanib. In some la...
What is the current status of trial NCT01782313?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2013-03-06. Estimated completion is 2016-12-28.
What conditions does trial NCT01782313 study?
This clinical trial studies the following conditions: Recurrent Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma.
What interventions are being tested in trial NCT01782313?
The interventions under investigation include: laboratory biomarker analysis (OTHER), tivozanib (DRUG).
Who is sponsoring clinical trial NCT01782313?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01782313 being conducted?
This trial has 5 study locations across Illinois, Iowa, Minnesota, Missouri, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Adult Soft Tissue Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01782313's enrollment target sits among peer trials
58 7th of 11 higher than 5 of 11 other Recurrent Adult Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Adult 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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