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ACTIVE NOT RECRUITING Phase 1

Lurbinectedin + Doxorubicin In Leiomyosarcoma

NCT05099666 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 62 participants
Start Date 2022-02-04
Est. Completion 2027-07
Phase Phase 1

Sponsor

Massachusetts General Hospital

1,948 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05099666

The ClinicalTrials.gov registry entry for NCT05099666 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05099666 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Massachusetts, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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 Leiomyosarcoma, Advanced Soft-tissue Sarcoma, Leiomyosarcoma Metastatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05099666?

The interventions under investigation include: Doxorubicin (DRUG), Lurbinectedin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05099666?

This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial