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NCT00210665
A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment
trial testing Trabectedin in Sarcoma. No longer available.
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 36 locations across Canada, United States, Israel |
Drugs / interventions tested
- Trabectedin (TRABECTEDIN) — full drug profile →
Conditions studied
- Sarcoma — all drugs for Sarcoma →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
15 and older, any sex, with Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study.
Samuels BL, Chawla S, Patel S, von Mehren M, et al · · 2013 · cited 101× · PMID 23385197 · DOI 10.1093/annonc/mds659 -
PPARγ agonists enhance ET-743-induced adipogenic differentiation in a transgenic mouse model of myxoid round cell liposarcoma.
Charytonowicz E, Terry M, Coakley K, Telis L, et al · · 2012 · cited 55× · PMID 22293175 · DOI 10.1172/jci60015 -
Soft tissue sarcoma clinical practice guidelines in oncology.
Demetri GD, Baker LH, Beech D, Benjamin R, et al · · 2005 · cited 39× · PMID 19817028 -
Trabectedin in soft tissue sarcomas.
Petek BJ, Loggers ET, Pollack SM, Jones RL. · · 2015 · cited 17× · PMID 25686274 · DOI 10.3390/md13020974 -
Early access provision: Awareness, educational needs and opportunities to improve oncology patients' access to care.
Krendyukov A, Singhvi S, Green-Morrison Y, Zabransky M. · · 2022 · cited 3× · PMID 36387084 · DOI 10.3389/fonc.2022.714516
Verify or expand the search:
- PubMed search for NCT00210665
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Trabectedin
Trials testing the same drug.
- NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A · Phase 1 · not yet recruiting
- NCT07076186 — Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS · Phase 2 · recruiting
- NCT05432791 — Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped W · Phase 2, PHASE3 · active not recruiting
- NCT04794127 — Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone. · Phase 2 · completed
- NCT04383119 — Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma · Phase 2 · recruiting
Other recruiting trials for Sarcoma
Currently open trials in the same condition.
- NCT07402577 — Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot · recruiting
- NCT07501026 — Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC) · Phase 2 · recruiting
- NCT07359911 — Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patient · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma · Phase 1 · recruiting
Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00210665 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 10 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00210665.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing