This research study involves the study drug lurbinectedin in combination with doxorubicin.
This research has two parts. The first part is being done to determine the tolerability of
lurbinectedin with doxorubicin in people with soft tissue sarcoma. The second part is a
randomized study to determine which is more effective at treating leiomyosarcoma,
lurbinectedin with doxorubicin or lurbinectedin alone.
This is an open label phase 1b/2 study exploring the safety and efficacy of lurbinectedin
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,
the randomized phase 2 trial in participants with advanced leiomyosarcoma (LMS) will
commence. Participants will be randomized 1:1 for enrollment to one of two treatment arms:
Arm 1: Lurbinectedin with Doxorubicin
Arm 2: Doxorubicin Monotherapy
This is a Phase Ib/II clinical trial. A Phase Ib clinical trial tests the safety of an
investigational drug combination and also tries to define the appropriate dose of the
investigational drugs to use for further studies. "Investigational" means that the drugs are
The U.S. Food and Drug Administration (FDA) has not approved lurbinectedin for this specific
disease but it has been approved for the treatment of small cell lung cancer.
The U.S. FDA has approved doxorubicin as a treatment option for soft-tissue sarcoma.
Lurbinectedin is a synthetically derived chemical that binds to DNA. The binding to DNA
likely induces cell death. Doxorubicin is a cytotoxic chemotherapy drug that kills cancer
cells by several mechanisms including binding to DNA.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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