MedPath

Trabectedin

Generic Name
Trabectedin
Brand Names
Yondelis
Drug Type
Small Molecule
Chemical Formula
C39H43N3O11S
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

Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS

Phase 2
Terminated
Conditions
Sarcoma
Interventions
First Posted Date
2010-04-15
Last Posted Date
2015-10-27
Lead Sponsor
Grupo Espanol de Investigacion en Sarcomas
Target Recruit Count
115
Registration Number
NCT01104298
Locations
🇪🇸

H. Sant Pau, Barcelona, Spain

🇪🇸

ICO Badalona, Badalona, Spain

🇪🇸

ICO Girona, Girona, Spain

and more 17 locations

A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

Phase 2
Completed
Conditions
Solid Tumor
Interventions
Drug: Placebo
First Posted Date
2008-11-06
Last Posted Date
2014-04-11
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
76
Registration Number
NCT00786838

An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Neoplasms
Interventions
First Posted Date
2007-12-24
Last Posted Date
2014-02-25
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
127
Registration Number
NCT00580112

Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma

Phase 2
Completed
Conditions
Liposarcoma,Myxoid
Interventions
First Posted Date
2007-12-24
Last Posted Date
2014-05-07
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
29
Registration Number
NCT00579501

Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

Phase 2
Completed
Conditions
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
First Posted Date
2007-12-07
Last Posted Date
2018-07-18
Lead Sponsor
Gynecologic Oncology Group
Target Recruit Count
71
Registration Number
NCT00569673
Locations
🇺🇸

St. John's Regional Health Center, Springfield, Missouri, United States

🇺🇸

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, United States

and more 34 locations

Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

Phase 2
Completed
Conditions
Sarcoma
Interventions
First Posted Date
2006-09-21
Last Posted Date
2017-12-12
Lead Sponsor
Gynecologic Oncology Group
Target Recruit Count
20
Registration Number
NCT00379145
Locations
🇺🇸

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus, New Britain, Connecticut, United States

🇺🇸

Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States

🇺🇸

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

and more 29 locations

ET 743 (Yondelis) in Men With Advanced Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-09-07
Last Posted Date
2013-01-18
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
50
Registration Number
NCT00147212
Locations
🇺🇸

Masachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

Phase 3
Completed
Conditions
Ovarian Cancer
Interventions
First Posted Date
2005-06-10
Last Posted Date
2014-06-27
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
672
Registration Number
NCT00113607
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