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Anti-tumor antibiotic

Lurbinectedin + Doxorubicin for Leiomyosarcoma (SaLuDo Trial)

Phase 2 & 3

Recruiting

Research Sponsored by PharmaMar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Histologically confirmed diagnosis of metastatic LMS

Must not have

Women who are pregnant or breast feeding and fertile patients (men and women) who are not using a highly effective method of contraception.

Prior treatment with anthracyclines, lurbinectedin or trabectedin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a combo of two chemo drugs can prolong progression-free survival in those with metastatic leiomyosarcoma.

Who is the study for?

Adults with metastatic Leiomyosarcoma who haven't had systemic therapy for their metastasis can join. They should have good organ function, no history of certain heart diseases or infections like HIV, and not be on drugs that affect liver enzymes. Women must not be pregnant and participants must use effective contraception.

What is being tested?

The trial is testing if adding Lurbinectedin to Doxorubicin improves the time patients live without their cancer getting worse compared to using Doxorubicin alone. It's a phase IIb/III study where one group gets both drugs and another only gets Doxorubicin.

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, vomiting, hair loss from Doxorubicin; Lurbinectedin may cause similar effects plus blood cell count changes which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer, LMS, has spread to other parts of my body.

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I can carry out all my self-care but cannot do heavy physical work.

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My kidneys are functioning well enough, with a creatinine clearance rate of 30 mL/min or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, and I use effective birth control.

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I have previously been treated with anthracyclines, lurbinectedin, or trabectedin.

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I have an infection that is not under control.

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I have a diagnosed muscle disease.

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I am allergic to ingredients in lurbinectedin or doxorubicin.

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My cancer is a low grade (grade I) leiomyosarcoma.

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I have chronic hepatitis or cirrhosis confirmed by positive tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Phase IIb (& Phase III if selected), Doxorubicin (dose C) + Lurbinectedin (dose D)Experimental Treatment2 Interventions

Participants will receive doxorubicin intravenously q3wk on day 1 of each treatment cycle (treatment cycle = three weeks).

Group II: Phase IIb (& Phase III if selected), Doxorubicin (dose A) + Lurbinectedin (dose B)Experimental Treatment2 Interventions

Participants will receive doxorubicin and lurbinectedin intravenously every three weeks (q3wk) on day 1 of each treatment cycle (treatment cycle = three weeks).

Group III: Phase IIb & Phase III, DoxorubicinActive Control1 Intervention

Participants will receive doxorubicin intravenously q3wk on day 1 of each treatment cycle (treatment cycle = three weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lurbinectedin

2022

Completed Phase 3

~780

Doxorubicin

2012