Numerous clinical trials evaluate trabectedin across various solid tumors, focusing on soft tissue sarcomas—including advanced liposarcoma and metastatic leiomyosarcoma—relapsed ovarian cancer, and recurrent high-grade meningioma. Spanning Phase I safety evaluations through Phase IV post-marketing studies, including pivotal Phase III comparative and combination regimens, these protocols encompass active recruiting, completed, active not recruiting, and terminated statuses. Research initiatives are supported by commercial sponsors such as Janssen and PharmaMar, alongside academic networks including the Fred Hutchinson Cancer Center and GEICO.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07444619 | RECRUITING | Soft Tissue Sarcomas |
M.D. Anderson Cancer Center |
2026-06-12 | PHASE1 |
| NCT03138161 | RECRUITING | Advanced Soft Tissue Sarcoma; Metastatic Soft Tissue Sarcoma |
Sarcoma Oncology Research Center, LLC |
2017-04-13 | PHASE1; PHASE2 |
| NCT03886311 | RECRUITING | Sarcoma |
Sarcoma Oncology Research Center, LLC |
2019-05-15 | PHASE2 |
| NCT06524583 | RECRUITING | Leiomyosarcoma Uterus |
UNICANCER |
2025-01-27 | PHASE2 |
| NCT04535271 | RECRUITING | Leiomyosarcoma |
Sarcoma Oncology Research Center, LLC |
2021-09-09 | PHASE2 |
| NCT02275286 | RECRUITING | Liposarcoma, Myxoid; Sarcoma, Soft Tissue; Leiomyosarcoma; Liposarcoma; Pleomorphic Liposarcoma |
Grupo Espanol de Investigacion en Sarcomas |
2014-11 | PHASE1; PHASE2 |
| NCT07076186 | RECRUITING | Uterine Leiomyosarcoma |
M.D. Anderson Cancer Center |
2025-10-02 | PHASE2 |
| NCT06263231 | RECRUITING | Sarcoma,Soft Tissue |
Intensity Therapeutics, Inc. |
2024-06-28 | PHASE3 |
| NCT04383119 | RECRUITING | Leiomyosarcoma of Ovary; Soft Tissue Sarcoma |
Italian Sarcoma Group |
2021-10-29 | PHASE2 |
| NCT04305548 | RECRUITING | Mesenchymal Chondrosarcoma |
Italian Sarcoma Group |
2021-09-14 | PHASE2 |
| NCT05597917 | RECRUITING | Soft Tissue Sarcoma |
Universität Münster |
2021-10-26 | PHASE3 |
| NCT03773510 | WITHDRAWN | Leiomyosarcoma; Liposarcoma; Synovial Sarcoma |
Italian Sarcoma Group |
2019-02-28 | PHASE3 |
| NCT04067115 | COMPLETED | Ewing Sarcoma |
Sarcoma Alliance for Research through Collaboration |
2021-01-05 | PHASE1; PHASE2 |
| NCT03023124 | COMPLETED | Solitary Fibrous Tumors |
Italian Sarcoma Group |
2018-03-04 | PHASE2 |
| NCT03838744 | COMPLETED | Advanced Soft Tissue Sarcoma |
Italian Sarcoma Group |
2020-05-20 | PHASE2 |
| NCT04794127 | COMPLETED | Liposarcoma, Myxoid; Liposarcoma, Dedifferentiated; Liposarcoma, Round Cell |
Mario Negri Institute for Pharmacological Research |
2022-02-02 | PHASE2 |
| NCT04008238 | COMPLETED | Soft Tissue Sarcoma Adult; Undifferentiated Pleomorphic Sarcoma; Epithelioid Sarcoma; Solitary Fibrous Tumors; Hemangioendothelioma; Desmoplastic Round Cell Tumor; Synovial Sarcoma |
Institut Bergonié |
2020-01-06 | |
| NCT05432791 | ACTIVE_NOT_RECRUITING | Locally Advanced Uterine Corpus Leiomyosarcoma; Metastatic Uterine Corpus Leiomyosarcoma; Stage III Uterine Corpus Leiomyosarcoma AJCC v8; Stage IV Uterine Corpus Leiomyosarcoma AJCC v8; Unresectable Uterine Corpus Leiomyosarcoma |
National Cancer Institute (NCI) |
2023-03-30 | PHASE2; PHASE3 |
| NCT05131386 | UNKNOWN | Soft Tissue Sarcoma; Bone Tumors; Small Round-cell Sarcomas |
Grupo Espanol de Investigacion en Sarcomas |
2021-05-28 | PHASE2 |
| NCT01710176 | COMPLETED | Localized High-risk Soft Tissue Sarcomas of the Extremities and Trunk Wall in Adults |
Italian Sarcoma Group |
2011-06-01 | PHASE3 |
| NCT03127215 | COMPLETED | Cancers With DNA Repair-Deficiency |
National Center for Tumor Diseases, Heidelberg |
2018-10-25 | PHASE2 |
| NCT04979442 | TERMINATED | Dedifferentiated Liposarcoma |
Rain Oncology Inc |
2021-07-14 | PHASE3 |
| NCT06050434 | Recruiting | Soft Tissue Sarcoma |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest|PharmaMar |
2023-10-31 | -- |
| NCT03164980 | TERMINATED | Quality of Life; Ovarian Cancer; Recurrent Ovarian Carcinoma |
North Eastern German Society of Gynaecological Oncology |
2018-02-01 | PHASE4 |
| NCT02359474 | UNKNOWN | Sarcoma |
Ludwig-Maximilians - University of Munich |
2014-12-19 | PHASE2 |
| NCT04076579 | COMPLETED | Sarcoma; Sarcoma Metastatic |
University of Michigan Rogel Cancer Center |
2020-03-17 | PHASE2 |
| NCT03470805 | COMPLETED | Ovarian Cancer |
Grupo Español de Investigación en Cáncer de Ovario |
2018-06-21 | PHASE2 |
| NCT04887961 | UNKNOWN | Relapsed Ovarian Cancer |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
2020-10-01 | PHASE2 |
| NCT03590210 | COMPLETED | Metastatic Adult Soft Tissue Sarcoma |
University Medicine Greifswald |
2018-06-08 | PHASE2 |
| NCT03496519 | WITHDRAWN | Solid Tumor, Adult |
University of Colorado, Denver |
2018-10-01 | PHASE1 |
| NCT05868889 | Completed | Ovarian Cancer |
Grupo Español de Investigación en Cáncer de Ovario |
2021-10-21 | -- |
| NCT05597917 | Recruiting | Soft Tissue Sarcoma |
Universität Münster|Anturec Pharmaceuticals GmbH |
2021-10-26 | Phase 3 |
| NCT02997358 | COMPLETED | Uterine or Soft Tissue Leiomyosarcoma |
Gustave Roussy, Cancer Campus, Grand Paris |
2017-01-18 | PHASE3 |
| NCT04979442 | Terminated | Dedifferentiated Liposarcoma |
Rain Oncology Inc |
2021-07-14 | Phase 3 |
| NCT03437070 | WITHDRAWN | Leiomyosarcoma |
University of Miami |
2019-06 | PHASE1 |
| NCT03690739 | TERMINATED | Recurrent Ovarian Carcinoma |
AGO Research GmbH |
2019-08-09 | PHASE3 |
| NCT03985722 | UNKNOWN | Sarcoma, Soft Tissue |
Grupo Espanol de Investigacion en Sarcomas |
2018-09-21 | PHASE1 |
| NCT03397186 | WITHDRAWN | Myxoid Liposarcoma; Round Cell Liposarcoma; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Metastatic Soft Tissue Sarcoma; Unresectable Soft Tissue Sarcoma |
Fred Hutchinson Cancer Center |
2018-06-19 | PHASE2 |
| NCT01379989 | COMPLETED | Ovarian Cancer |
Mario Negri Institute for Pharmacological Research |
2011-06 | PHASE3 |
| NCT03085225 | COMPLETED | Ovarian Carcinoma; Soft Tissue Sarcoma |
Institut Bergonié |
2017-05-05 | PHASE1 |
| NCT03074318 | TERMINATED | Metastatic Leiomyosarcoma; Metastatic Liposarcoma; Unresectable Leiomyosarcoma; Unresectable Liposarcoma |
Fred Hutchinson Cancer Center |
2017-09-28 | PHASE1; PHASE2 |
| NCT02929394 | TERMINATED | Sarcoma, Soft Tissue |
European Organisation for Research and Treatment of Cancer - EORTC |
2017-11-07 | PHASE3 |
| NCT02805725 | COMPLETED | Soft-tissue Sarcomas |
Institut Bergonié |
2015-12 | PHASE1; PHASE2 |
| NCT03884972 | WITHDRAWN | Refractory Chronic Lymphocytic Leukemia; Refractory Small Lymphocytic Lymphoma |
M.D. Anderson Cancer Center |
2019-06-18 | PHASE1 |
| NCT02194231 | COMPLETED | Malignant Pleural Mesothelioma |
Mario Negri Institute for Pharmacological Research |
2013-07 | PHASE2 |
| NCT02398058 | COMPLETED | Soft Tissue Sarcoma; Bone Tumor |
Italian Sarcoma Group |
2014-07-20 | PHASE1 |
| NCT02993705 | COMPLETED | Carcinosarcoma, Ovarian; Carcinosarcomas Uterine |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
2017-02-22 | PHASE2 |
| NCT02247544 | COMPLETED | Liposarcoma; Leiomyosarcoma |
Italian Sarcoma Group |
2014-03 | PHASE2 |
| NCT02903004 | COMPLETED | Ovarian Neoplasms |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
2016-04-11 | PHASE3 |
| NCT02672527 | COMPLETED | Soft Tissue Sarcoma |
Gustave Roussy, Cancer Campus, Grand Paris |
2015-01-22 | PHASE3 |
| NCT01303094 | COMPLETED | Soft Tissue Sarcoma; Uterine Sarcoma |
Centre Oscar Lambret |
2011-02 | PHASE2 |
| NCT01735071 | COMPLETED | Ovarian Epithelial Cancer Recurrent |
Mario Negri Institute for Pharmacological Research |
2013-07 | PHASE2 |
| NCT01846611 | COMPLETED | Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms |
Janssen Research & Development, LLC |
2013-10-16 | PHASE3 |
| NCT02234050 | COMPLETED | Recurrent High Grade Meningioma |
European Organisation for Research and Treatment of Cancer - EORTC |
2015-07 | PHASE2 |
| NCT02249702 | COMPLETED | Leiomyosarcoma |
Mario Negri Institute for Pharmacological Research |
2010-04 | PHASE2 |
| NCT02066675 | COMPLETED | Metastatic and Locally Advanced Soft Tissue Tumor Patients Unfit to Receive; Standard Chemotherapy |
Italian Sarcoma Group |
2014-02 | PHASE2 |
| NCT01692678 | COMPLETED | Advanced or Metastatic Liposarcoma or Leiomyosarcoma |
Xian-Janssen Pharmaceutical Ltd. |
2012-08-07 | PHASE3 |
| NCT01343277 | COMPLETED | Advanced Liposarcoma or Leiomyosarcoma |
Janssen Research & Development, LLC |
2011-06 | PHASE3 |
| NCT01426633 | COMPLETED | Leiomyosarcoma; Liposarcoma |
Heidelberg University |
2011-11 | PHASE1 |
| NCT01772979 | UNKNOWN | BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype |
Catholic University of the Sacred Heart |
2011-06 | PHASE2 |
| NCT01273493 | COMPLETED | Neoplasm Metastases; Hepatic Insufficiency |
Janssen Research & Development, LLC |
2010-12 | PHASE1 |
| NCT01189253 | TERMINATED | Sarcoma |
European Organisation for Research and Treatment of Cancer - EORTC |
2011-05 | PHASE2; PHASE3 |
| NCT02131480 | COMPLETED | Uterus Leiomyosarcoma; Soft Tissue Leiomyosarcoma |
Gustave Roussy, Cancer Campus, Grand Paris |
2010-06 | PHASE2 |
| NCT01339754 | COMPLETED | Pancreatic Cancer |
IRCCS San Raffaele |
2011-02 | PHASE2 |
| NCT01104298 | TERMINATED | Sarcoma |
Grupo Espanol de Investigacion en Sarcomas |
2009-11 | PHASE2 |
| NCT01267084 | COMPLETED | Neoplasm Metastases |
Janssen Research & Development, LLC |
2011-02 | PHASE1; PHASE2 |
| NCT01273480 | COMPLETED | Neoplasm Metastases |
Janssen Research & Development, LLC |
2010-12 | PHASE1 |
| NCT00796120 | COMPLETED | Sarcoma |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2008-11 | PHASE3 |
| NCT00379145 | COMPLETED | Sarcoma |
Gynecologic Oncology Group |
2007-06 | PHASE2 |
| NCT00569673 | COMPLETED | Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer |
Gynecologic Oncology Group |
2008-03 | PHASE2 |
| NCT01453283 | COMPLETED | Solid Tumors |
National Cancer Institute (NCI) |
2006-12-20 | PHASE1 |
| NCT00580112 | COMPLETED | Breast Neoplasms |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-06 | PHASE2 |
| NCT00113607 | COMPLETED | Ovarian Cancer |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-04 | PHASE3 |
| NCT00070109 | COMPLETED | Previously Treated Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Ewing Sarcoma; Peripheral Primitive Neuroectodermal Tumor |
Children's Oncology Group |
2008-01 | PHASE2 |
| NCT00579501 | COMPLETED | Liposarcoma,Myxoid |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-04 | PHASE2 |
| NCT00786838 | COMPLETED | Solid Tumor |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2008-10 | PHASE2 |
| NCT00170573 | COMPLETED | Ovarian Cancer |
North Eastern German Society of Gynaecological Oncology |
2001-09 | PHASE2 |
| NCT00072670 | COMPLETED | Prostate Cancer |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-01 | PHASE2 |
| NCT00005625 | COMPLETED | Sarcoma |
Memorial Sloan Kettering Cancer Center |
1999-12 | PHASE2 |
| NCT00017030 | COMPLETED | Sarcoma |
Memorial Sloan Kettering Cancer Center |
2001-02 | PHASE2 |
| NCT00027508 | TERMINATED | Malignant Mesothelioma |
PharmaMar |
2001-07 | PHASE2 |
| NCT00003939 | COMPLETED | Brain and Central Nervous System Tumors; Endometrial Cancer; Gastrointestinal Stromal Tumor; Ovarian Cancer; Sarcoma; Small Intestine Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
PHASE2 | |
| NCT00002904 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
European Organisation for Research and Treatment of Cancer - EORTC |
1996-02 | PHASE1 |
| NCT00050414 | COMPLETED | Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2002-10 | PHASE2 |
| NCT00050440 | COMPLETED | Endometrial Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female Urogenital Neoplasms |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2002-07 | PHASE2 |
| NCT00102609 | COMPLETED | Soft Tissue Sarcoma; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-04 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-06)
Check the
Trabectedin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.