Trabectedin

Generic Name: Trabectedin

Brand Names: Yondelis

Drug Type: Small Molecule

Chemical Formula: C_₃₉H_₄₃N_₃O_₁₁S

CAS Number: 114899-77-3

Unique Ingredient Identifier: ID0YZQ2TCP

Background: Trabectedin, also referred as ET-743 during its development, is a marine-derived antitumor agent discovered in the Carribean tunicate Ecteinascidia turbinata and now produced synthetically. Trabectedin has a unique mechanism of action. It binds to the minor groove of DNA interfering with cell division and genetic transcription processes and DNA repair machinery. It is approved for use in Europe, Russia and South Korea for the treatment of advanced soft tissue sarcoma. It is currently under evaluation for the treatment of breast cancer, prostate cancer, in addition to pediatric sarcomas. Both the European Commission and the U.S. Food and Drug Administration (FDA) have approved trabectedin as an orphan drug in soft tissue sarcomas and ovarian cancer. On October 23, 2015, the FDA approved trabectedin, (as Yondelis), for the treatment of specific soft tissue sarcomas.

Indication: 用于治疗急性淋巴母细胞白血病、晚期软组织肉瘤及复发卵巢癌。

Associated Conditions: Metastatic Leiomyosarcoma, Metastatic Liposarcoma, Platinum Sensitive Relapsed Ovarian Cancer, Unresectable Leiomyosarcoma, Unresectable Liposarcoma

Clinical Trials

Interest of Post-operative Chemotherapy in Patients With Localised Uterine Leiomyosarcoma Suspected of Having a High Risk of Recurrence Based on a Biological Test Performed on the Tumour

Phase 2

Recruiting

Conditions: Leiomyosarcoma Uterus

Interventions: Drug: Doxorubicin
Drug: Trabectedin

First Posted Date: 2024-07-29

Last Posted Date: 2025-03-30

Lead Sponsor: UNICANCER

Target Recruit Count: 198

Registration Number: NCT06524583

Locations: 🇫🇷
Centre Léon Berard, Lyon, France
🇫🇷
Institut Paoli Calmettes, Marseille, France
🇫🇷
La Timone University Hospital, Marseille, France

and more 22 locations

A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)

Phase 3

Recruiting

Conditions: Sarcoma,Soft Tissue

Interventions: Drug: Eribulin
Drug: INT230-6
Drug: Trabectedin
Drug: Pazopanib

First Posted Date: 2024-02-16

Last Posted Date: 2025-04-09

Lead Sponsor: Intensity Therapeutics, Inc.

Target Recruit Count: 333

Registration Number: NCT06263231

Locations: 🇺🇸
Profound Research LLC, Farmington Hills, Michigan, United States
🇩🇪
Universitäres Krebszentrum (UCCL), Leipzig, Germany
🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 14 locations

Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD

Completed

Conditions: Ovarian Cancer

First Posted Date: 2023-05-22

Last Posted Date: 2023-05-24

Lead Sponsor: Grupo Español de Investigación en Cáncer de Ovario

Target Recruit Count: 43

Registration Number: NCT05868889

Locations: 🇪🇸
Hospital Universitario Reina Sofía, Córdoba, Spain

tTF-NGR Randomized Study - STS

Phase 3

Recruiting

Conditions: Soft Tissue Sarcoma

Interventions: Drug: Trabectedin
Biological: tTF-NGR

First Posted Date: 2022-10-28

Last Posted Date: 2025-04-04

Lead Sponsor: Universität Münster

Target Recruit Count: 126

Registration Number: NCT05597917

Locations: 🇩🇪
Medizinische Hochschule Hannover, Hannover, Germany
🇩🇪
Klinikum rechts der Isar der technischen Universität München, München, Germany
🇩🇪
HELIOS Klinikum Bad Saarow, Bad Saarow, Germany

and more 6 locations

Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working

Phase 2

Active, not recruiting

Conditions: Locally Advanced Uterine Corpus Leiomyosarcoma
Stage IV Uterine Corpus Leiomyosarcoma AJCC v8
Stage III Uterine Corpus Leiomyosarcoma AJCC v8
Metastatic Uterine Corpus Leiomyosarcoma
Unresectable Uterine Corpus Leiomyosarcoma

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
Drug: Olaparib
Drug: Pazopanib
Drug: Temozolomide
Drug: Trabectedin
Procedure: Transthoracic Echocardiography Test

First Posted Date: 2022-06-27

Last Posted Date: 2025-04-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 190

Registration Number: NCT05432791

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Alaska Women's Cancer Care, Anchorage, Alaska, United States
🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States

and more 142 locations

Multicohort Trial of Trabectedin and Low-dose Radiation Therapy in Advanced/Metastatic Sarcomas

Phase 2

Recruiting

Conditions: Small Round-cell Sarcomas
Soft Tissue Sarcoma
Bone Tumors

Interventions: Drug: Trabectedin

First Posted Date: 2021-11-23

Last Posted Date: 2023-03-27

Lead Sponsor: Grupo Espanol de Investigacion en Sarcomas

Target Recruit Count: 85

Registration Number: NCT05131386

Locations: 🇪🇸
Hospital General Universitario Gregorio Marañón, Madrid, Comunidad De Madrid, Spain
🇪🇸
Hospital Universitario de Canarias, Tenerife, Islas Canarias, Spain
🇪🇸
Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña, Spain

and more 4 locations

Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma

Phase 3

Terminated

Conditions: Dedifferentiated Liposarcoma

Interventions: Drug: RAIN-32
Drug: Trabectedin

First Posted Date: 2021-07-28

Last Posted Date: 2025-01-14

Lead Sponsor: Rain Oncology Inc

Target Recruit Count: 175

Registration Number: NCT04979442

Locations: 🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇺🇸
University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

and more 68 locations