Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813327
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-04-02
Brief Title:
Neoadjuvant ADI-PEG 20 Ifosfamide Radiotherapy in Soft Tissue Sarcoma
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase III Trial of Neoadjuvant ADI-PEG 20 in Combination With Ifosfamide and Radiotherapy in Soft Tissue Sarcoma STS
Status:
RECRUITING
Status Verified Date:
2024-03
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:
In this study patients with soft tissue sarcoma STS will receive ADI-PEG 20 and ifosfamide in combination with radiation as neoadjuvant therapy In phase I of the study up to 5 dose levels will be tested to find the recommended phase II dose RP2D after which patients enrolling to phase II will be treated at that dose level to assess efficacy
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None