Lurbinectedin + Doxorubicin for Leiomyosarcoma

Recruiting at5 trial locations

Overseen by Gregory Cote, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, lurbinectedin, combined with an existing chemotherapy drug, doxorubicin, in patients with advanced leiomyosarcoma. The goal is to see if this combination is safe and more effective than doxorubicin alone. Both drugs work by damaging the DNA in cancer cells, leading to their death. Lurbinectedin is a synthetic marine-derived anticancer agent that has shown promise in treating certain types of cancer.

Research Team

Gregory Cote, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

My hepatitis B virus load is undetectable with treatment.

My organs and bone marrow are functioning well.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

I am not taking strong or moderate drugs that affect enzyme activity.

I have had interstitial pneumonitis or pulmonary fibrosis.

Pregnant women

Treatment Details

Interventions

• Doxorubicin (Alkylating agent)
• Lurbinectedin (Other)

Trial Overview 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.

Participant Groups

Group I: Lurbinectedin + Doxorubicin at RP2D Experimental Treatment 2 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 I Experimental Treatment 2 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 Monotherapy Active Control 1 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

Doxorubicin is already approved in Canada, Japan for the following indications:

Approved in Canada as Doxorubicin for:

• Breast cancer
• Ovarian cancer
• Bladder cancer
• Lymphomas
• Leukemias
• Multiple myeloma
• Kaposi's sarcoma
• Soft tissue sarcomas

Approved in Japan as Doxorubicin for:

• Breast cancer
• Ovarian cancer
• Bladder cancer
• Lymphomas
• Leukemias
• Multiple myeloma
• Kaposi's sarcoma
• Soft tissue sarcomas

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Jazz Pharmaceuticals

Industry Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland