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NCT04887298 · ClinicalTrials.gov registry record · Phase 1
Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas (STS) with Pulmonary Metastases
A Phase 1 study, sponsored by Moleculin Biotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT04887298: Completed Phase 1 study, sponsored by Moleculin Biotech.
NCT04887298 is a Phase 1 study that has completed, run by Moleculin Biotech. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04887298, a Phase 1 study, has completed, sponsored by Moleculin Biotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate.
Primary Outcome
Number of patients with a dose limiting toxicity (DLT) at each dose evaluated
Interventions
- DRUG Liposomal Annamycin (L-Annamycin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-06-05 |
| Est. Completion | 2024-08-06 |
| Phase | Phase 1 |
What the finished NCT04887298 record still lists
NCT04887298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Liposomal Annamycin (L-Annamycin) is the first listed.
NCT04887298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04887298 about?
NCT04887298 is a clinical study titled "Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas (STS) with Pulmonary Metastases". This is a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung...
What is the current status of trial NCT04887298?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2021-06-05. Estimated completion is 2024-08-06.
What interventions are being tested in trial NCT04887298?
The interventions under investigation include: Liposomal Annamycin (L-Annamycin) (DRUG).
Who is sponsoring clinical trial NCT04887298?
This trial is sponsored by Moleculin Biotech, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04887298's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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