NCT05099666

Lurbinectedin + Doxorubicin In Leiomyosarcoma

A Phase 1b/2 Trial of Lurbinectedin Plus Doxorubicin in Leiomyosarcoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open label phase 1b/2 study exploring the safety and efficacy of lurbinectedin with doxorubicin. \- The phase 1b trial will follow a standard 3+3 design. Upon determination of the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of lurbinectedin plus doxorubicin, the randomized phase 2 trial in participants with advanced leiomyosarcoma (LMS) will commence. Participants will be randomized 1:1 for enrollment to one of two treatment arms: * Arm 1: Lurbinectedin with Doxorubicin * Arm 2: Doxorubicin Monotherapy This is a Phase Ib/II clinical trial. A Phase Ib clinical trial tests the safety of an investigational drug combination and also tries to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied. The U.S. Food and Drug Administration (FDA) has not approved lurbinectedin for this specific disease but it has been approved for the treatment of small cell lung cancer. The U.S. FDA has approved doxorubicin as a treatment option for soft-tissue sarcoma. Lurbinectedin is a synthetically derived chemical that binds to DNA. The binding to DNA likely induces cell death. Doxorubicin is a cytotoxic chemotherapy drug that kills cancer cells by several mechanisms including binding to DNA.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-04
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2021-10-29
• Last updated: 2026-04-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study