Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)

Status Recruiting

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

Clinical Trial Details

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

View Details

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