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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

Wash-out periods:

Participant signed and dated written informed consent of the patient obtained before any study-specific procedure

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to approximately 28 months

Awards & highlights

No Placebo-Only Group

Study Summary

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

Eligibility Criteria

Inclusion Criteria

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

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You have signed and dated a written informed consent prior to any study-related activity.

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You are at least 18 years old.

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Your diagnosis is a confirmed metastatic form of LMS.

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Your medical imaging shows evidence of detectable illness as per the Response Evaluation Criteria in Solid Tumors version 1.1 guidelines.

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You have not received systemic therapy for metastatic disease in the past or any prior anthracyclines, however previous chemotherapy without anthracycline in an adjuvant or neoadjuvant setting is acceptable.

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You have an Eastern Cooperative Oncology Group performance status of no more than 1.

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You possess satisfactory blood, kidney, metabolic and liver function.

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You have a hemoglobin level of 9.0 or higher, an ANC above 2.0 x 10^9/L, and a platelet count greater than 100 x 109/L (after any RBC transfusions).

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Your ALT and AST levels are at or below 3.0 times the upper limit of normal.

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You have a total bilirubin level of no more than 1.5 times the upper limit of normal or a direct bilirubin level within the normal range if your total bilirubin is higher than the upper limit.

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Your albumin level is at least 3.0 g/dL.

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Your calculated creatinine clearance (CrCL) is 30 mL/min or higher, as determined by Cockcroft and Gault's formula.

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Your left ventricular ejection fraction is greater than 50%, as assessed by MUGA or ECHO.

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You have not had systemic treatment for a minimum of three weeks.

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It has been a minimum of three weeks since your last major surgery and one week since your last minor procedure.

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It has been at least two weeks since your last radiotherapy.

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Women of childbearing potential must provide proof that they are not capable of bearing a child.

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

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

2017

Completed Phase 2

~50

Doxorubicin

2012

Completed Phase 3

~7940

0 / 18Eligibility 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.

All > Osa > Leiomyosarcoma