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

An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer

Conditions: Ovarian Cancer

Interventions: Drug: Trabectedin + PLD

First Posted Date: 2018-02-26

Last Posted Date: 2018-02-26

Lead Sponsor: Suriya Yessentayeva

Target Recruit Count: 60

Registration Number: NCT03446495

Locations: 🇰🇿
Almaty regional oncological dispensary, Almaty, Kazakhstan
🇰🇿
West Kazakhstan regional oncology dispensary, Oral, Kazakhstan
🇰🇿
Almaty oncological center, Almaty, Kazakhstan

and more 6 locations

Trabectedin, Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma

Phase 1

Withdrawn

Conditions: Leiomyosarcoma

Interventions: Drug: Trabectedin
Drug: Doxorubicin
Drug: Olaratumab

First Posted Date: 2018-02-19

Last Posted Date: 2019-03-18

Lead Sponsor: University of Miami

Registration Number: NCT03437070

Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma

Phase 2

Withdrawn

Conditions: Round Cell Liposarcoma
Myxoid Liposarcoma
Unresectable Soft Tissue Sarcoma
Stage III Soft Tissue Sarcoma AJCC v7
Stage IV Soft Tissue Sarcoma AJCC v7
Metastatic Soft Tissue Sarcoma

Interventions: Procedure: Biopsy
Other: Laboratory Biomarker Analysis
Drug: Trabectedin

First Posted Date: 2018-01-11

Last Posted Date: 2019-09-10

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT03397186

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma

Phase 1

Recruiting

Conditions: Metastatic Soft Tissue Sarcoma
Advanced Soft Tissue Sarcoma

Interventions: Drug: Trabectedin
Drug: Ipilimumab
Drug: Nivolumab

First Posted Date: 2017-05-03

Last Posted Date: 2025-02-24

Lead Sponsor: Sarcoma Oncology Research Center, LLC

Target Recruit Count: 250

Registration Number: NCT03138161

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

Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors

Phase 2

Completed

Conditions: Cancers With DNA Repair-Deficiency

Interventions: Drug: Physician's choice
Drug: Olaparib
Drug: Trabectedin

First Posted Date: 2017-04-25

Last Posted Date: 2024-05-08

Lead Sponsor: National Center for Tumor Diseases, Heidelberg

Target Recruit Count: 102

Registration Number: NCT03127215

Locations: 🇩🇪
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Mainz, Germany
🇩🇪
Universitätsklinikum Frankfurt, Frankfurt, Germany
🇩🇪
Medizinische Fakultät der TU Dresden, Dresden, Germany

and more 6 locations

Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery

Phase 1

Terminated

Conditions: Metastatic Liposarcoma
Unresectable Leiomyosarcoma
Unresectable Liposarcoma
Metastatic Leiomyosarcoma

Interventions: Drug: Avelumab
Drug: Trabectedin

First Posted Date: 2017-03-08

Last Posted Date: 2022-04-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 35

Registration Number: NCT03074318

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor

Phase 2

Completed

Conditions: Solitary Fibrous Tumors

Interventions: Drug: Trabectedin
Drug: Adriamycin
Drug: Dacarbazine

First Posted Date: 2017-01-18

Last Posted Date: 2024-12-09

Lead Sponsor: Italian Sarcoma Group

Target Recruit Count: 23

Registration Number: NCT03023124

Locations: 🇮🇹
Nuovo Ospedale di Prato, Prato, Firenze, Italy
🇮🇹
Policlinico Universitario Campus Biomedico, Roma, RM, Italy
🇮🇹
IRCCS Istituto ortopedico Rizzoli, Bologna, Italy

and more 3 locations