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

A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma

Phase 1
Completed
Conditions
Soft Tissue Sarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Interventions
First Posted Date
2005-02-01
Last Posted Date
2013-01-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
41
Registration Number
NCT00102609

Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2004-09-03
Last Posted Date
2012-07-02
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
40
Registration Number
NCT00002904
Locations
🇫🇷

Centre Oscar Lambret, Lille, France

🇩🇪

Martin Luther Universitaet, Halle Saale, Germany

🇩🇪

Universitats-Krankenhaus Eppendorf, Hamburg, Germany

and more 46 locations

Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma

Phase 2
Completed
Conditions
Brain and Central Nervous System Tumors
Endometrial Cancer
Gastrointestinal Stromal Tumor
Ovarian Cancer
Sarcoma
Small Intestine Cancer
First Posted Date
2004-06-03
Last Posted Date
2012-09-24
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
132
Registration Number
NCT00003939

Ecteinascidin 743 in Treating Children With Refractory Solid Tumors

Phase 1
Completed
Conditions
Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
First Posted Date
2004-04-26
Last Posted Date
2014-02-21
Lead Sponsor
Children's Oncology Group
Target Recruit Count
13
Registration Number
NCT00006463
Locations
🇺🇸

University of Mississippi Medical Center, Jackson, Mississippi, United States

🇺🇸

Hackensack University Medical Center, Hackensack, New Jersey, United States

🇺🇸

State University of New York - Upstate Medical University, Syracuse, New York, United States

and more 44 locations

Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma

Phase 2
Completed
Conditions
Sarcoma
First Posted Date
2004-04-19
Last Posted Date
2013-06-19
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT00005625
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma

Phase 2
Completed
Conditions
Sarcoma
First Posted Date
2004-03-11
Last Posted Date
2013-06-26
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT00017030
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

🇺🇸

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

🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma

Phase 2
Terminated
Conditions
Malignant Mesothelioma
First Posted Date
2004-01-15
Last Posted Date
2015-02-24
Lead Sponsor
PharmaMar
Registration Number
NCT00027508
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

🇺🇸

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

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

and more 1 locations

A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2003-11-11
Last Posted Date
2014-04-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
59
Registration Number
NCT00072670
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

Phase 2
Completed
Conditions
Recurrent Ewing Sarcoma
Previously Treated Childhood Rhabdomyosarcoma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Peripheral Primitive Neuroectodermal Tumor
Interventions
Other: pharmacological study
First Posted Date
2003-10-07
Last Posted Date
2018-09-14
Lead Sponsor
Children's Oncology Group
Target Recruit Count
50
Registration Number
NCT00070109
Locations
🇺🇸

Childrens Memorial Hospital, Chicago, Illinois, United States

🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇨🇦

Hospital for Sick Children, Toronto, Ontario, Canada

and more 11 locations

A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer

Phase 2
Completed
Conditions
Liposarcoma
Leiomyosarcoma
Interventions
First Posted Date
2003-05-19
Last Posted Date
2014-09-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
271
Registration Number
NCT00060944
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