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Clinical Trial Summary

This study will enroll patients who have a diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except gastrointestinal stromal tumors and Kaposi's sarcoma) from any site.


Clinical Trial Description

The primary objectives of this pilot study are to assess the feasibility of pharmacokinetically-guided, patient-individualized dosing and to obtain preliminary evidence of anti-tumor activity of intravenous ascorbate in combination with gemcitabine to inform a subsequent Phase II trial. Soft tissue and bone sarcomas will be studied as different cohorts given the differences in biology and historical responses to single agent gemcitabine in these disease types. As such, 10 evaluable patients per disease cohort will be included. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04634227
Study type Interventional
Source University of Iowa
Contact John Rieth, MD
Phone 319-356-1616
Email john-rieth@uiowa.edu
Status Recruiting
Phase Early Phase 1
Start date November 24, 2020
Completion date August 31, 2024

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