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

Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients

Phase 1

Recruiting

Conditions: Sarcoma, Soft Tissue
Liposarcoma, Myxoid
Liposarcoma
Pleomorphic Liposarcoma
Leiomyosarcoma

Interventions: Drug: Trabectedin
Radiation: Radiotherapy

First Posted Date: 2014-10-27

Last Posted Date: 2023-05-31

Lead Sponsor: Grupo Espanol de Investigacion en Sarcomas

Target Recruit Count: 199

Registration Number: NCT02275286

Locations: 🇮🇹
Istituto Clinico Humanitas, Rozzano, Milan, Italy
🇮🇹
Centro di Referimento Ocologico, Aviano, Italy
🇮🇹
Candiolo Cancer Institute, Candiolo, Italy

and more 14 locations

Activity of Trabectedin or Gemcitabine + Docetaxel in Uterine Leiomyosarcoma

Phase 2

Completed

Conditions: Leiomyosarcoma

Interventions: Drug: gemcitabine + docetaxel
Drug: trabectedin

First Posted Date: 2014-09-25

Last Posted Date: 2017-12-06

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 168

Registration Number: NCT02249702

Locations: 🇮🇹
Policlinico Umberto I, Roma, RM, Italy
🇮🇹
Ospedale Sant'Anna, Como, Italy
🇮🇹
Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy

and more 30 locations

Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma

Phase 2

Completed

Conditions: Leiomyosarcoma
Liposarcoma

Interventions: Drug: Trabectedin

First Posted Date: 2014-09-25

Last Posted Date: 2021-11-01

Lead Sponsor: Italian Sarcoma Group

Target Recruit Count: 105

Registration Number: NCT02247544

Locations: 🇮🇹
Azienda Ospedaliera Sant'Anna, Como, CO, Italy
🇮🇹
IRST IRCCS Meldola, Meldola, FC, Italy
🇮🇹
A.O. Spedali Civili, Brescia, BS, Italy

and more 18 locations

Trabectedin for Recurrent Grade II/III Meningioma

Phase 2

Completed

Conditions: Recurrent High Grade Meningioma

Interventions: Other: Local standard of care
Drug: Trabectedin

First Posted Date: 2014-09-09

Last Posted Date: 2019-02-28

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 90

Registration Number: NCT02234050

Locations: 🇦🇹
Landesnervenklinik Wagner Jauregg, Linz, Austria
🇧🇪
U.Z. Leuven - Campus Gasthuisberg, Leuven, Belgium
🇧🇪
CHU Dinant Godinne - UCL Namur, Yvoir, Belgium

and more 44 locations

ATREUS - Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)

Phase 2

Completed

Conditions: Malignant Pleural Mesothelioma

Interventions: Drug: Trabectedin

First Posted Date: 2014-07-18

Last Posted Date: 2020-01-23

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 145

Registration Number: NCT02194231

Locations: 🇮🇹
Istituto Oncologico Veneto - IOV, Padova, PD, Italy
🇮🇹
P.O. Spedalli Civili, Brescia, BS, Italy
🇮🇹
Istituto Clinico Humanitas, Rozzano, MI, Italy

and more 5 locations

Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma

Phase 2

Completed

Conditions: Uterus Leiomyosarcoma
Soft Tissue Leiomyosarcoma

Interventions: Drug: Doxorubicin
Drug: Trabectedin

First Posted Date: 2014-05-06

Last Posted Date: 2017-01-26

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 110

Registration Number: NCT02131480

Locations: 🇫🇷
Gustave Roussy Cancer Campus Grand Paris, Villejuif, Val de Marne, France

Trabectedin First Line Therapy In Unfit Sarcoma Study

Phase 2

Completed

Conditions: Metastatic and Locally Advanced Soft Tissue Tumor Patients Unfit to Receive
Standard Chemotherapy

Interventions: Drug: Trabectedin

First Posted Date: 2014-02-19

Last Posted Date: 2018-04-11

Lead Sponsor: Italian Sarcoma Group

Target Recruit Count: 24

Registration Number: NCT02066675

Locations: 🇮🇹
Ospedali Riuniti di Bergamo, Bergamo, BG, Italy
🇮🇹
Ospedale Galliera, Genova, Genovs, Italy
🇮🇹
I.R.C.C. - Unit of Medical Oncology, Candiolo, Torino, Italy

and more 13 locations

A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase 3

Completed

Conditions: Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms

Interventions: Drug: Trabectedin
Drug: DOXIL
Drug: Dexamethasone

First Posted Date: 2013-05-03

Last Posted Date: 2019-04-01

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 581

Registration Number: NCT01846611

Study With Trabectedin in BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype Ovarian Cancer

Phase 2

Conditions: BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype

Interventions: Drug: Trabectedin

First Posted Date: 2013-01-21

Last Posted Date: 2013-01-21

Lead Sponsor: Catholic University of the Sacred Heart

Target Recruit Count: 100

Registration Number: NCT01772979

Locations: 🇮🇹
Catholic University of Sacred Heart, Rome, Italy

Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy

Phase 3

Active, not recruiting

Conditions: Localized High-risk Soft Tissue Sarcomas of the Extremities and Trunk Wall in Adults

Interventions: Drug: epirubicin 60 mg/m2/day (days 1, 2) and ifosfamide 3 g/m2/day (days 1, 2, 3)
Drug: gemcitabine 900 mg/m2 (days 1 and 8) and docetaxel 75 mg/m2 (day 8)
Drug: trabectedin 1.3 mg/m2
Drug: high-dose ifosfamide 14 g/m2, given in in 14 days
Drug: etoposide 150 mg/m2/day (days 1, 2, 3) and ifosfamide 3g/m2/day (days 1, 2, 3)
Drug: gemcitabine 1800 mg/m2 (day 1) and dacarbazine 500 mg/m2 (day 1)

First Posted Date: 2012-10-19

Last Posted Date: 2023-09-13

Lead Sponsor: Italian Sarcoma Group

Target Recruit Count: 550

Registration Number: NCT01710176

Locations: 🇪🇸
Hospital Son Espases, Palma de Mallorca, Spain
🇪🇸
Hospital Vall D'Hebron, Barcelona, Spain
🇪🇸
Hospital Clínico de Malaga, Malaga, Spain

and more 12 locations

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