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NCT05813327 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma
A Phase 1 study of Soft Tissue Sarcoma and Sarcoma,Soft Tissue, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT05813327 is a Phase 1 study of Soft Tissue Sarcoma and Sarcoma,Soft Tissue that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 6 participants, below the 79-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05813327, a Phase 1 study of Soft Tissue Sarcoma and Sarcoma,Soft Tissue, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Mesna
- RADIATION Radiotherapy
- DRUG Ifosfamide
- DRUG ADI PEG20
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2024-03-14 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05813327
The ClinicalTrials.gov registry entry for NCT05813327 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 79-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (92% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 4 interventions - of which Mesna is the first listed.
NCT05813327 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05813327 about?
NCT05813327 is a clinical study titled "Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma". 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 wil...
What is the current status of trial NCT05813327?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2024-03-14. Estimated completion is 2028-05-31.
What conditions does trial NCT05813327 study?
This clinical trial studies the following conditions: Soft Tissue Sarcoma, Sarcoma,Soft Tissue, Sts.
What interventions are being tested in trial NCT05813327?
The interventions under investigation include: Mesna (DRUG), Radiotherapy (RADIATION), Ifosfamide (DRUG), ADI PEG20 (DRUG).
Who is sponsoring clinical trial NCT05813327?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05813327 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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