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NCT05099666 · ClinicalTrials.gov record · last posted 2026-08-27

Lurbinectedin + Doxorubicin In Leiomyosarcoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started2022-02-04
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from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-28
Primary completion pushed: 2026-07 → 2026-12
2026-08-28
Completion pushed: 2027-07 → 2028-07
Trial Details
NCT Number NCT05099666
Lead Sponsor Massachusetts General Hospital
Collaborators: Jazz Pharmaceuticals
Conditions Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma, Advanced Leiomyosarcoma, Leiomyosarcoma Metastatic
Enrollment 62 participants
Start Date 2022-02-04
Primary Completion 2026-12 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-27