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Clinical trials for trabectedin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    51 result(s) found for: trabectedin. Displaying page 2 of 3.
    EudraCT Number: 2015-002760-16 Sponsor Protocol Number: IB2015-04 Start Date*: 2015-10-19
    Sponsor Name:INSTITUT BERGONIE
    Full Title: Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly trabectedin combined with Metronomic Cyclophosphamide in Patients with Advanced Pretreated Soft-tissue Sarcomas. A Phase I/II stu...
    Medical condition: Adult patients with unresectable locally advanced or metastatic soft-tissue sarcoma.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10039494 Sarcoma NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001549-26 Sponsor Protocol Number: TRASTS Start Date*: 2014-11-03
    Sponsor Name:GEIS
    Full Title: Phase I-II prospective trial, multicenter, open label, exploring the combination of Trabectedin plus Radiotherapy in Soft Tissue Sarcoma patients.
    Medical condition: Soft Tissue Sarcoma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000929-40 Sponsor Protocol Number: ET743-SAR-3007 Start Date*: 2016-08-09
    Sponsor Name:Janssen Research & Development, LLC
    Full Title: A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma
    Medical condition: advanced L-sarcoma (liposarcoma or leiomyosarcoma)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024627 Liposarcoma PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024189 Leiomyosarcoma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004690-14 Sponsor Protocol Number: NA Start Date*: 2021-01-12
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL (REPRAB study – MITO 36)
    Medical condition: Ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    22.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10026311 Malignant neoplasm of ovary and other uterine adnexa LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061535 Ovarian neoplasm PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061344 Peritoneal neoplasm PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-004967-21 Sponsor Protocol Number: ET743-OVC-1001 Start Date*: 2008-10-20
    Sponsor Name:Pharma Mar, S.A.
    Full Title: A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
    Medical condition: - to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in subjects with advanced solid tumor malignancies when administered at a ther...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10007050 Cancer LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-002276-17 Sponsor Protocol Number: ET-B-025-02 Start Date*: 2006-08-24
    Sponsor Name:Pharma Mar SA, Sociedad Unipersonal
    Full Title: Phase II Study of Yondelis® in Men with Advanced Prostate Carcinoma Estudio fase II con Yondelis en hombres con cáncer de próstata avanzado
    Medical condition: Advanced Prostate Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    7.1 10036909 PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-003733-41 Sponsor Protocol Number: ISG-MCS Start Date*: 2021-02-23
    Sponsor Name:ITALIAN SARCOMA GROUP
    Full Title: Phase II study on Trabectedin in advanced rearranged Mesenchymal chondrosarcoma (MCS)
    Medical condition: Patients with advanced, histological and molecularly (presence of the HEY1-NCOA2 fusion) centrally confirmed diagnosis of MCS, with an evidence of RECIST progression within the 6 months prior to st...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10041298 Soft tissue sarcomas histology unspecified HLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001394-23 Sponsor Protocol Number: RAIN-3201 Start Date*: 2021-10-04
    Sponsor Name:Rain Therapeutics, Inc.
    Full Title: A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients with Dedifferentiated Liposarcoma
    Medical condition: Dedifferentiated liposarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10024631 Liposarcoma NOS LLT
    21.1 100000004864 10024633 Liposarcoma stage unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) AT (Prematurely Ended) PL (Prematurely Ended) DE (Prematurely Ended) BE (Completed) IE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-000794-31 Sponsor Protocol Number: ET-B-027-06 Start Date*: 2007-08-01
    Sponsor Name:Pharma Mar, S.A.
    Full Title: Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) in Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-), HER2 overexpressing tumors and BRCA...
    Medical condition: Progressive metastatic breast cancer previously treated in the following subpopulation of patients: Group A: Triple negative phenotype: Estrogen Receptor, Progesterone Receptor and HER-2 negative s...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed) IT (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-024287-17 Sponsor Protocol Number: PACT-18 Start Date*: 2011-02-03
    Sponsor Name:FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
    Full Title: Salvage therapy with trabectidin in metastatic pancreatic adenocarcinoma: a single-arm phase II trial.
    Medical condition: metastatic pancreatic adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051971 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-008922-55 Sponsor Protocol Number: GEIS20 Start Date*: 2009-06-04
    Sponsor Name:Grupo Español de Investigación en Sarcomas
    Full Title: ENSAYO FASE II ALEATORIZADO, ABIERTO, MULTICÉNTRICO Y PROSPECTIVO DE DOXORRUBICINA vs TRABECTEDINA Y DOXORRUBICINA EN PRIMERA LÍNEA DE PACIENTES CON SARCOMA DE PARTES BLANDAS AVANZADOS NO OPERABLES...
    Medical condition: Sarcoma de partes blandas avanzados no operables y/o metastásicos
    Disease: Version SOC Term Classification Code Term Level
    9 10041299 Soft tissue sarcomas HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) PT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-003535-38 Sponsor Protocol Number: 1447-STBSG Start Date*: 2017-07-04
    Sponsor Name:European Organisation for Research and Treatment of Cancer
    Full Title: Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma
    Medical condition: Metastatic soft tissue sarcoma
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075333 Soft tissue sarcoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended) NL (Prematurely Ended) PL (Prematurely Ended) ES (Prematurely Ended) FR (Completed) CY (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003866-42 Sponsor Protocol Number: IRFMN-OVA-6152 Start Date*: 2012-12-13
    Sponsor Name:IST. DI RICERCHE FARMACOLOG. M. NEGRI
    Full Title: Multicenter, randomized, non-comparative, open-label phase II trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with pla...
    Medical condition: adult women with platinum partially sensitive recurring ovarian cancer.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10033271 Ovarian neoplasia LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-005029-36 Sponsor Protocol Number: NOGGO_S16/COMPASS Start Date*: 2017-09-05
    Sponsor Name:NOGGO e.V.
    Full Title: Comparison of QoL between Trabectedin / PLD and standard platinum-based therapy in patients with platinum sensitive recurrent ovarian, fallopian tube and peritoneal cancer - Intergroup-Study of NOG...
    Medical condition: Ovarian Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-005276-16 Sponsor Protocol Number: ET743-OVA-301 Start Date*: 2005-10-27
    Sponsor Name:Pharma Mar S.A.
    Full Title: An open-label multicenter randomized Phase 3 study comparing the combination of DOXIL®/CAELYX® and YONDELIS® with DOXIL®/CAELYX® alone in subjects with advanced relapsed ovarian cancer.
    Medical condition: Advanced relapsed ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    9.1 10033130 Ovarian cancer NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed) SE (Completed) DE (Completed) ES (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-014889-26 Sponsor Protocol Number: EORTC 62091 Start Date*: 2011-12-15
    Sponsor Name:EORTC (European Organisation for Research and Treatment of Cancer)
    Full Title: TRUSTS: A phase IIb/III multicenter study comparing the efficacy of TRabectedin administered as a 3-hour or 24-hour infusion to doxorubicin in patients with advanced or metastatic Untreated Soft Ti...
    Medical condition: Histologically proven advanced and/or metastatic malignant soft tissue sarcoma intermediate/high grade, excluding the following tumor types :  Well-differentiated liposarcoma  Embryonal rhabdomyo...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041299 Soft tissue sarcomas HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) HU (Completed) DK (Completed) AT (Completed) NL (Completed) SK (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-016017-24 Sponsor Protocol Number: 2009-016017-24 Start Date*: 2010-04-07
    Sponsor Name:IST. DI RICERCHE FARMACOLOG. M. NEGRI
    Full Title: A PHASE II RANDOMIZED NON COMPARATIVE STUDY ON THE ACTIVITY OF TRABECTEDIN OR GEMCITABINE + DOCETAXEL IN METASTATIC OR LOCALLY RELAPSED UTERINE LEIOMYOSARCOMA PRETREATED WITH CONVENTIONAL CHEMOT...
    Medical condition: Leiomiosarcomi uterini metastatici o in progressione locale
    Disease: Version SOC Term Classification Code Term Level
    9.1 10046799 LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-001298-17 Sponsor Protocol Number: 362/11 Start Date*: 2012-04-05
    Sponsor Name:POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    Full Title: Phase II study on ET-743 in BRCA1 and BRCA2 mutation carrie and BRCAness phenotype advanced ovarian cancer patients.
    Medical condition: advaced ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033129 Ovarian neoplasms malignant (excl germ cell) HLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003183-13 Sponsor Protocol Number: OLATRA Start Date*: 2018-05-25
    Sponsor Name:GEICO - Grupo Español de Investigación en Cáncer de Ovario
    Full Title: Phase-II study of olaparib as maintenance therapy after response to trabectedinpegylated liposomal doxorubicin in recurrent ovarian carcinoma.
    Medical condition: Ovarian Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10033131 Ovarian carcinoma LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004472-30 Sponsor Protocol Number: MITO23 Start Date*: 2015-12-02
    Sponsor Name:FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    Full Title: Randomized phase III trial on Trabectedin (ET-743) vs clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype patients
    Medical condition: recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10006888 Ca ovary LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed) ES (Prematurely Ended)
    Trial results: (No results available)
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