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NCT01692678
A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma
Phase 3 trial testing Trabectedin in Advanced or Metastatic Liposarcoma or Leiomyosarcoma in 16 participants. Completed in 11 October 2016.
11 October 2016
Quick facts
| Lead sponsor | Xian-Janssen Pharmaceutical Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 7 August 2012 |
| Primary completion | 11 October 2016 |
| Estimated completion | 11 October 2016 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Trabectedin (TRABECTEDIN) — full drug profile →
- Dacarbazine (dacarbazine) — full drug profile →
Conditions studied
- Advanced or Metastatic Liposarcoma or Leiomyosarcoma — all drugs for Advanced or Metastatic Liposarcoma or Leiomyosarcoma →
Sponsor
Xian-Janssen Pharmaceutical Ltd. — full company profile →
Who can join
15 and older, any sex, with Advanced or Metastatic Liposarcoma or Leiomyosarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to find the optimal dose of trabectedin for Chinese patients with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated (in any order) with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group is superior to dacarbazine group (Part 2).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01692678
- 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 Xian-Janssen Pharmaceutical Ltd. trials
Trials by the same sponsor.
- NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
- NCT07302360 — A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis · recruiting
- NCT06082986 — A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China · completed
- NCT03617016 — Preliminarily Evaluate the Efficacy of Domperidone in Adult Chinese Participants With Functional Dyspepsia · Phase 4 · completed
- NCT03220867 — Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions i · Phase 1 · withdrawn
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 NCT01692678 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xian-Janssen Pharmaceutical Ltd.
- Last refreshed: 11 July 2018
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/NCT01692678.
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