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NCT05099666 · ClinicalTrials.gov registry record · Phase 1
Lurbinectedin + Doxorubicin In Leiomyosarcoma
A Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
- 6
- Study locations
NCT05099666: Active Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, sponsored by Massachusetts General Hospital.
NCT05099666 is a Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 62 participants, below the 135-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (54% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05099666, a Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
- 6
- Study locations
Study Summary
This research study involves the study drug lurbinectedin in combination with doxorubicin. This research has two parts. The first part is being done to determine the tolerability of lurbinectedin with doxorubicin in people with soft tissue sarcoma. The second part is a randomized study to determine which is more effective at treating leiomyosarcoma, lurbinectedin with doxorubicin or lurbinectedin alone.
Primary Outcome
The MTD will be defined as the dose where less than 1 in 3 patients experience a DLT. At least 6 patients must be treated at this dose level. DLTs will be defined as toxicities experienced by participants enrolled to the phase 1b portion of the trial that are considered at least possibly related to the treatment regimen, occur during the first cycle of treatment.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Lurbinectedin
Study Locations (6)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Arizona
- Mayo Arizona - Phoenix
Florida
- Mayo Jacksonville - Jacksonville
Minnesota
- Mayo Rochester - Rochester
New York
- Memorial Sloan Kettering - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2022-02-04 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What the registry record for NCT05099666 still lists
NCT05099666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 135-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (54% lower).
The record links to 4 conditions, with Metastatic Soft Tissue Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Doxorubicin is the first listed.
NCT05099666 lists 6 locations in 5 states (Massachusetts, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT05099666 about?
NCT05099666 is a clinical study titled "Lurbinectedin + Doxorubicin In Leiomyosarcoma". This research study involves the study drug lurbinectedin in combination with doxorubicin. This research has two parts. The first part is being done to determine the tolerability of lurbinectedin with doxorubicin in people with soft tissue sarcoma. The second part is a randomized study to determine...
What is the current status of trial NCT05099666?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2022-02-04. Estimated completion is 2027-07.
What conditions does trial NCT05099666 study?
This clinical trial studies the following conditions: Metastatic Soft Tissue Sarcoma, Advanced Soft Tissue Sarcoma, Advanced Leiomyosarcoma, Leiomyosarcoma Metastatic.
What interventions are being tested in trial NCT05099666?
The interventions under investigation include: Doxorubicin (DRUG), Lurbinectedin (DRUG).
Who is sponsoring clinical trial NCT05099666?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05099666 being conducted?
This trial has 6 study locations across Arizona, Florida, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05099666's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Soft Tissue 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.
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