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

Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

Phase 2

Recruiting

Conditions: Leiomyosarcoma of Ovary
Soft Tissue Sarcoma

Interventions: Drug: Gemcitabine
Drug: Trabectedin

First Posted Date: 2020-05-12

Last Posted Date: 2024-12-20

Lead Sponsor: Italian Sarcoma Group

Target Recruit Count: 100

Registration Number: NCT04383119

Locations: 🇮🇹
Nuovo Ospedale di Prato, Prato, Firenze, Italy
🇮🇹
IRCCS Fondazione Piemonte per l'Oncologia, Candiolo, Torino, Italy
🇮🇹
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST, Meldola, FC, Italy

and more 14 locations

Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

Phase 2

Recruiting

Conditions: Mesenchymal Chondrosarcoma

Interventions: Drug: Trabectedin

First Posted Date: 2020-03-12

Last Posted Date: 2024-12-20

Lead Sponsor: Italian Sarcoma Group

Target Recruit Count: 16

Registration Number: NCT04305548

Locations: 🇮🇹
Nuovo Ospedale di Prato, Prato, Firenze, Italy
🇮🇹
Policlinico Universitario Campus Biomedico, Roma, RM, Italy
🇮🇹
Fondazione del Piemonte per l'Oncologia IRCC Candiolo, Candiolo, Torino, Italy

and more 4 locations

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Phase 2

Active, not recruiting

Conditions: Sarcoma
Sarcoma Metastatic

Interventions: Drug: Olaparib
Drug: Trabectedin

First Posted Date: 2019-09-03

Last Posted Date: 2024-07-29

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 29

Registration Number: NCT04076579

Locations: 🇺🇸
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States

SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients

Phase 1

Completed

Conditions: Ewing Sarcoma

Interventions: Drug: Trabectedin 1 MG [Yondelis]
Drug: Irinotecan
Diagnostic Test: tumor biopsy
Other: 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging

First Posted Date: 2019-08-26

Last Posted Date: 2025-04-29

Lead Sponsor: Sarcoma Alliance for Research through Collaboration

Target Recruit Count: 37

Registration Number: NCT04067115

Locations: 🇺🇸
Boston Children's Hospital / Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
National Cancer Institute, Bethesda, Maryland, United States

and more 3 locations

Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients

Not Applicable

Recruiting

Conditions: Desmoplastic Round Cell Tumor
Synovial Sarcoma
Hemangioendothelioma
Soft Tissue Sarcoma Adult
Epithelioid Sarcoma
Undifferentiated Pleomorphic Sarcoma
Solitary Fibrous Tumors

Interventions: Drug: Trabectedin

First Posted Date: 2019-07-05

Last Posted Date: 2023-03-03

Lead Sponsor: Institut Bergonié

Target Recruit Count: 200

Registration Number: NCT04008238

Locations: 🇫🇷
Institut Bergonie, Bordeaux, France

Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma

Phase 2

Recruiting

Conditions: Sarcoma

Interventions: Drug: Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC]
Drug: Nivolumab IV Soln 100 MG/10ML
Drug: Trabectedin 0.25 MG/1 VIAL Intravenous Powder for Solution

First Posted Date: 2019-03-22

Last Posted Date: 2025-02-24

Lead Sponsor: Sarcoma Oncology Research Center, LLC

Target Recruit Count: 200

Registration Number: NCT03886311

Locations: 🇺🇸
Sarcoma Oncology Center, Santa Monica, California, United States

Trabectedin and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Resistant or Intolerant to a BTK Inhibitor

Phase 1

Withdrawn

Conditions: Refractory Chronic Lymphocytic Leukemia
Refractory Small Lymphocytic Lymphoma

Interventions: Drug: Trabectedin
Drug: Venetoclax

First Posted Date: 2019-03-21

Last Posted Date: 2023-09-25

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT03884972

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin

Phase 3

Withdrawn

Conditions: Leiomyosarcoma
Liposarcoma
Synovial Sarcoma

Interventions: Drug: Trabectedin continuation
Drug: Trabectedin discontinuation

First Posted Date: 2018-12-12

Last Posted Date: 2019-05-13

Lead Sponsor: Italian Sarcoma Group

Registration Number: NCT03773510

Locations: 🇮🇹
Irccs Istituto Oncologico Veneto (Iov), Padova, Italy
🇮🇹
Fondazione IRCCS INT Milano, Milano, Italy
🇮🇹
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST, Meldola, FC, Italy

and more 12 locations

Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer

Phase 3

Terminated

Conditions: Recurrent Ovarian Carcinoma

Interventions: Drug: Carboplatin
Drug: Gemcitabine
Drug: Trabectedin
Drug: Bevacizumab
Drug: PLD
Drug: Paclitaxel
Drug: Cisplatin

First Posted Date: 2018-10-01

Last Posted Date: 2022-02-24

Lead Sponsor: AGO Research GmbH

Target Recruit Count: 9

Registration Number: NCT03690739

Locations: 🇩🇪
Sozialstiftung Bamberg, Bamberg, Germany
🇩🇪
Kreiskrankenhaus "Johann Kentmann", Torgau, Germany
🇩🇪
Hochtaunus-Kliniken, Bad Homburg, Germany

and more 26 locations

Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas

Phase 2

Completed

Conditions: Metastatic Adult Soft Tissue Sarcoma

Interventions: Drug: Trabectedin
Drug: Nivolumab

First Posted Date: 2018-07-18

Last Posted Date: 2022-11-08

Lead Sponsor: University Medicine Greifswald

Target Recruit Count: 92

Registration Number: NCT03590210

Locations: 🇩🇪
Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum Berlin-Brandenburg, Bad Saarow, Germany
🇩🇪
Medizinische Fakultät "Carl Gustav Carus" der TU Dresden, Medizinische Klinik I, Dresden, Germany
🇩🇪
Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C, Hämatologie und Onkologie, Greifswald, Germany

and more 6 locations

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