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NCT04393454 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy
A Phase 2 study, sponsored by Albert Einstein College of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT04393454: Clinical Trial Phase 2 study, sponsored by Albert Einstein College of Medicine.
NCT04393454 is a Phase 2 study that was terminated before completion, run by Albert Einstein College of Medicine. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04393454, a Phase 2 study, was terminated before completion, sponsored by Albert Einstein College of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
To evaluate the efficacy of sirolimus by estimating the overall response rate (ORR) as assessed by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) in patients with metastatic dMMR solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment).
Primary Outcome
To evaluate the efficacy of sirolimus in patients with metastatic mismatch repair deficient (dMMR) solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment), ORR will be determined. For this study ORR will be defined as the percentage of patients who achieve either a complete response (CR = disappearance of all target tumors); or a partial response (PR = ≥30% decrease in the sum of the longest diameters of target tumors) based on Response Evaluati
Interventions
- DRUG Sirolimus 2mg Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-11-16 |
| Est. Completion | 2023-05-16 |
| Phase | Phase 2 |
Why NCT04393454 stopped before completion
NCT04393454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Sirolimus 2mg Tablet is the first listed.
NCT04393454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04393454 about?
NCT04393454 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy". To evaluate the efficacy of sirolimus by estimating the overall response rate (ORR) as assessed by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) in patients with metastatic dMMR solid cancer after immunotherapy (either due to disease progression or to inability to tolerate t...
What is the current status of trial NCT04393454?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2020-11-16. Estimated completion is 2023-05-16.
What interventions are being tested in trial NCT04393454?
The interventions under investigation include: Sirolimus 2mg Tablet (DRUG).
Who is sponsoring clinical trial NCT04393454?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04393454's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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