← Back to Search

Alkylating agent

Lurbinectedin + Doxorubicin for Leiomyosarcoma

Phase 1 & 2

Recruiting

Led By Gregory Cote, M.D. Ph.D

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

For participants with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying if the combination of lurbinectedin with doxorubicin is safe and tolerable in people with soft tissue sarcoma. They will also compare the two to see which is more effective in treating leiomyosarcoma.

Who is the study for?

Adults with measurable soft tissue sarcoma, specifically leiomyosarcoma, who have no curative treatment options available. They must be over 18, not pregnant or breastfeeding, willing to use contraception, and have adequate organ function and bone marrow reserves. Prior cancer treatments are restricted.Check my eligibility

What is being tested?

The trial is testing the combination of lurbinectedin and doxorubicin versus lurbinectedin alone for treating leiomyosarcoma. It has two parts: one for tolerability assessment and another randomized part to compare effectiveness.See study design

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues such as fatigue, nausea, hair loss (alopecia), heart problems due to doxorubicin's known cardiotoxicity, risk of infections from low white blood cell counts (neutropenia), liver function changes.

Eligibility Criteria

Inclusion Criteria

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

Select...

My hepatitis B virus load is undetectable with treatment.

Select...

I am 18 years old or older.

Select...

I can take care of myself but may not be able to do heavy physical work.

Select...

My cancer is an advanced leiomyosarcoma with no cure through combined treatments.

Select...

I have tissue samples from previous procedures available for testing.

Select...

I had hepatitis C but have been treated and cured.

Select...

My sarcoma is advanced or has spread, and there are no cure-focused treatments left for me.

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

Study Objectives

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

Primary outcome measures

PFS rate of lurbinectedin with doxorubicin compared to doxorubicin alone in participants with advanced LMS

The maximum tolerated dose (MTD) of lurbinectedin with doxorubicin in participants with advanced soft-tissue sarcoma

Secondary outcome measures

Disease Control Rate Phase 1b

Disease Control Rate Phase 2

Number of Participants Treatment Related Adverse Events

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Lurbinectedin + Doxorubicin at RP2DExperimental Treatment2 Interventions

The randomized two arm phase 2 trial will begin following the determination of the RP2D for lurbinectedin and doxorubicin. Participants will be randomized 1:1 to enroll to either Arm 1 or Arm 2 Participants enrolled to Arm 1 will receive Lurbinectedin with Doxorubicin at the RP2D defined during the phase 1b portion of the trial.

Group II: Lurbinectedin + Doxorubicin Phase IExperimental Treatment2 Interventions

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. A treatment cycle will be defined as 21 consecutive days. Treatment will be administered on an outpatient basis Lurbinectedin Doxorubicin

Group III: Doxorubicin MonotherapyActive Control1 Intervention

The randomized two arm phase 2 trial will begin following the determination of the RP2D for lurbinectedin and doxorubicin. Participants will be randomized 1:1 to enroll to either Arm 1 or Arm 2 Participants enrolled to Arm 2 will receive Doxorubicin at the standard dose of 75 mg/m2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~7940

Lurbinectedin

2022

Completed Phase 2

~90

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,419 Total Patients Enrolled

Jazz PharmaceuticalsIndustry Sponsor

248 Previous Clinical Trials

34,223 Total Patients Enrolled

Gregory Cote, M.D. Ph.DPrincipal InvestigatorMassachusetts General Hospital

Media Library

Doxorubicin (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT05099666 — Phase 1 & 2

Soft Tissue Sarcoma Research Study Groups: Lurbinectedin + Doxorubicin Phase I, Lurbinectedin + Doxorubicin at RP2D, Doxorubicin Monotherapy

Soft Tissue Sarcoma Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT05099666 — Phase 1 & 2

Doxorubicin (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05099666 — Phase 1 & 2

Frequently Asked Questions

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

Are individuals still able to join this experiment?

"Affirmative. The information on clinicaltrials.gov verifies that this medical trial is actively seeking participants, which it began doing since February 4th 2022 and most recently updated the data on February 14th 2022. 62 patients must be enrolled from two different locations for the study to proceed."

Answered by AI

What are the desired outcomes of this clinical investigation?

"This clinical trial is slated to run for a maximum of 5 years, with the primary goal being assessing lurbinectedin's Maximum Tolerated Dose (MTD) in conjunction with doxorubicin on patients suffering from advanced soft-tissue sarcoma. Secondary endpoints include Overall Survival Rate Phase 2, Number of Participants Treatment Related Adverse Events as defined by NCI CTCAE v5.0 and Progression Free Survival Phase 1b."

Answered by AI

Is this particular medical trial being done for the first time?

"Currently, 368 Lurbinectedin studies are actively being conducted in 1953 cities across 66 countries. In 1997, the pharmaceutical company Alfacell sponsored a study with 300 patients that eventually completed its Phase 3 trial and drug approval process. Since then, 690 research projects have been launched worldwide."

Answered by AI

What conditions has Lurbinectedin been effective in alleviating?

"Lurbinectedin is a viable therapeutic option for cancer patients diagnosed with lymphoma, Hodgkins Disease, carcinoma, bronchogenic tumours and neuroblastomas."

Answered by AI

How many participants are actively engaged in this trial?

"Affirmative. Clinicaltrials.gov illustrates that this research endeavour is actively enrolling participants, having been posted on February 4th 2022 and re-edited 14 days later. Across two sites, 62 patients are required for the study's completion."

Answered by AI

Are there any related research projects concerning Lurbinectedin?

"Currently, there are 368 studies dedicated to researching Lurbinectedin with 121 being in the advanced Phase 3 stage. Although many of these trails originate from Providence, Rhode island, a total of 23882 locations worldwide are evaluating this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lurbinectedin + Doxorubicin In Leiomyosarcoma

Gregory Cote 2022. "Lurbinectedin + Doxorubicin In Leiomyosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05099666.

All > Leiomyosarcoma Boston > Leiomyosarcoma