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NCT04634227 · ClinicalTrials.gov registry record · Early Phase 1
Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)
A Early Phase 1 study of Sarcoma and Soft Tissue Sarcoma, sponsored by University of Iowa.
- Active
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04634227: Active Early Phase 1 study of Sarcoma and Soft Tissue Sarcoma, sponsored by University of Iowa.
NCT04634227 is a Early Phase 1 study of Sarcoma and Soft Tissue Sarcoma that is active but no longer recruiting, run by University of Iowa. The registered enrollment target is 30 participants, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04634227, a Early Phase 1 study of Sarcoma and Soft Tissue Sarcoma, is active but no longer recruiting, sponsored by University of Iowa.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary endpoint of interest is PFS12 defined as the proportion of patients without progressive disease per RECIST 1.1 at 12 weeks after treatment initiation. A sample size of 10 evaluable patients per disease cohort (soft tissue and bone) will allow for the estimation of PFS12 per the 90% exact confidence intervals as follows: PFS12 Exact 90% confidence interval: 1/10 10% (1-39%); 2/10 20% (4-51%); 3/10 30% (9-61%); 4/10 40% (15-70%); 5/10 50% (22-78%); 6/10 60% (30-85%); 7/10 70% (39-91%
Conditions Studied
Interventions
- DRUG Ascorbate
Study Locations (1)
Iowa
- John - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2026-12-31 |
| Phase | Early Phase 1 |
What the registry record for NCT04634227 still lists
NCT04634227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which Ascorbate is the first listed.
NCT04634227 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT04634227 about?
NCT04634227 is a clinical study titled "Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)". 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.
What is the current status of trial NCT04634227?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2020-11-24. Estimated completion is 2026-12-31.
What conditions does trial NCT04634227 study?
This clinical trial studies the following conditions: Sarcoma, Soft Tissue Sarcoma, Bone Sarcoma, Metastatic Bone Tumor, Unresectable Soft Tissue Sarcoma.
What interventions are being tested in trial NCT04634227?
The interventions under investigation include: Ascorbate (DRUG).
Who is sponsoring clinical trial NCT04634227?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04634227 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04634227's enrollment target sits among peer trials
30 86th of 122 higher than 31 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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