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Lurbinectedin + Doxorubicin In Leiomyosarcoma

NCT05099666 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-04-13

No results posted yet for this 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.

Conditions

  • Advanced Soft-tissue Sarcoma
  • Metastatic Soft-tissue Sarcoma
  • Advanced Leiomyosarcoma
  • Leiomyosarcoma Metastatic

Interventions

DRUG

Lurbinectedin

Dosage per protocol, escalation per protocol, IV over 60 minutes (± 5 minute infusion window), schedule per protocol

DRUG

Doxorubicin

Dosage per protocol, IV per institutional standards of practice and the FDA package insert, schedule per protocol

Sponsors & Collaborators

Principal Investigators

  • Gregory Cote, M.D. Ph.D · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-04
Primary Completion
2026-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099666 on ClinicalTrials.gov