Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634227
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2020-11-16
Brief Title:
Gemcitabine Plus Ascorbate for Sarcoma in Adults Pilot
Sponsor:
Mohammed Milhem MBBS
Organization:
University of Iowa
Study Overview
Official Title:
A Pilot Study of Gemcitabine Plus High-Dose Ascorbate in Locally Advanced Unresectable or Metastatic Soft Tissue and Bone Sarcomas in Adults
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Kaposis sarcoma from any site
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None