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Anti-tumor antibiotic

Lurbinectedin + Doxorubicin for Leiomyosarcoma

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 28 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 28 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 28 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 28 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PFS by IRC

Secondary outcome measures

Change in Quality of Life by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire

Clearance of Lurbinectedin and Doxorubicin in the Plasma

Clinical Benefit Rate (CBR) by IRC and IA

+10 more

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 2

~90

Doxorubicin

2012

Completed Phase 3

~7940

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

PharmaMarLead Sponsor

90 Previous Clinical Trials

11,410 Total Patients Enrolled

5 Trials studying Leiomyosarcoma

1,118 Patients Enrolled for Leiomyosarcoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current total of participants in this research project?

"Affirmative. According to clinicaltrials.gov, this research is actively looking for participants and was first advertised on October 15th 2023 with the latest update being made a day later. The study demands 240 patients from only 1 location."

Answered by AI

Are there any opportunities to volunteer for this clinical trial?

"That is correct. According to the information provided on clinicaltrials.gov, this medical research project began recruiting participants as of October 15th 2023 and was recently revised on October 16th 2023. The team are currently seeking 240 individuals from a single site for participation in their study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma

2023. "Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088290.

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