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 Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma
- Conditions
- Advanced or Metastatic Liposarcoma or Leiomyosarcoma
- Interventions
- First Posted Date
- 2012-09-25
- Last Posted Date
- 2018-07-11
- Lead Sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Target Recruit Count
- 16
- Registration Number
- NCT01692678
Tabectedin to Treat Children and Adolescents With Cancer
- Conditions
- Solid Tumors
- First Posted Date
- 2011-10-17
- Last Posted Date
- 2017-07-02
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 12
- Registration Number
- NCT01453283
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access
- Conditions
- Soft Tissue Sarcoma
- First Posted Date
- 2011-09-01
- Last Posted Date
- 2011-09-01
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Registration Number
- NCT01427582
- Locations
- 🇺🇸
University of Texas Southwestern, Dallas, Texas, United States
INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer
- Conditions
- Ovarian Cancer
- Interventions
- First Posted Date
- 2011-06-23
- Last Posted Date
- 2022-02-09
- Lead Sponsor
- Mario Negri Institute for Pharmacological Research
- Target Recruit Count
- 617
- Registration Number
- NCT01379989
- Locations
- 🇦🇹
Medizinische Universitat Graz, Graz, Austria
🇳🇱Radboud University Medical Centre, Nijmegen, NL, Netherlands
🇳🇴Stavanger University Hospital, Stavanger, Norway
A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma
- Conditions
- Advanced Liposarcoma or Leiomyosarcoma
- Interventions
- First Posted Date
- 2011-04-28
- Last Posted Date
- 2016-08-26
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 579
- Registration Number
- NCT01343277
Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy
- First Posted Date
- 2011-04-21
- Last Posted Date
- 2014-08-11
- Lead Sponsor
- IRCCS San Raffaele
- Target Recruit Count
- 25
- Registration Number
- NCT01339754
- Locations
- 🇮🇹
Istituto Scientifico H. San Raffaele, Milan, Italy
Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma
- First Posted Date
- 2011-02-24
- Last Posted Date
- 2019-05-31
- Lead Sponsor
- Centre Oscar Lambret
- Target Recruit Count
- 53
- Registration Number
- NCT01303094
- Locations
- 🇫🇷
Saint-Jacques Hospital, Besancon, France
🇫🇷Centre François Baclesse, Caen, France
🇫🇷Centre Jean Perrin, Clermont Ferrand, France
A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction
- Conditions
- Neoplasm MetastasesHepatic Insufficiency
- Interventions
- First Posted Date
- 2011-01-10
- Last Posted Date
- 2016-02-15
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 15
- Registration Number
- NCT01273493
A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies
- Conditions
- Neoplasm Metastases
- Interventions
- First Posted Date
- 2010-12-24
- Last Posted Date
- 2015-10-14
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 12
- Registration Number
- NCT01267084
Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma
- Conditions
- Sarcoma
- Interventions
- Other: laboratory biomarker analysisProcedure: quality-of-life assessment
- First Posted Date
- 2010-08-26
- Last Posted Date
- 2014-08-08
- Target Recruit Count
- 133
- Registration Number
- NCT01189253
- Locations
- 🇫🇷
ASSISTANCE PUBLIQUE - HôPITAUX DE MARSEILLE - HôPITAL DE LA TIMONE, Marseille, France
🇺🇸Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
🇩🇪Universitaetsklinikum Koeln, Koeln, Germany
Drug Development Updates
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