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NCT03838744: TOMAS2
Randomized Trial in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments.
Phase 2 trial testing Standard arm: Trabectedin in monotherapy in Advanced Soft Tissue Sarcoma in 130 participants. Completed in 29 November 2024.
29 November 2024
Quick facts
| Lead sponsor | Italian Sarcoma Group |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 130 |
| Start date | 20 May 2020 |
| Primary completion | 29 November 2024 |
| Estimated completion | 29 November 2024 |
| Sites | 13 locations across Italy |
Drugs / interventions tested
- Standard arm: Trabectedin in monotherapy — full drug profile →
- Experimental arm: Trabectedin + Olaparib — full drug profile →
Conditions studied
- Advanced Soft Tissue Sarcoma — all drugs for Advanced Soft Tissue Sarcoma →
Sponsor
Italian Sarcoma Group — full company profile →
Who can join
18 and older, any sex, with Advanced Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase II study in patient with advanced Soft Tissue Sarcoma (STS) patients who have already received or are not suitable, for a doxorubicin-based treatment.
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 NCT03838744
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Soft Tissue Sarcoma
Currently open trials in the same condition.
- NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis · Phase 1, PHASE2 · recruiting
- NCT06981637 — Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Contr · Phase 2 · recruiting
- NCT06062927 — Geno-radiomics Based Model for Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma · recruiting
- NCT05333458 — Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial · Phase 2 · recruiting
- NCT04028063 — Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas · Phase 2 · recruiting
Other Italian Sarcoma Group trials
Trials by the same sponsor.
- NCT07265661 — Surgical Timing After Preoperative Hypofractionated Radiotherapy for Localized Extremity and Trunk Soft Tissue Sarcoma · NA · not yet recruiting
- NCT07328425 — Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS · Phase 2 · recruiting
- NCT06375941 — Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars · recruiting
- NCT04274023 — Study on TSR-042 in Advanced Clear Cell Sarcoma · Phase 2 · terminated
- NCT04383119 — Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma · Phase 2 · 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 NCT03838744 (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 Italian Sarcoma Group
- Last refreshed: 4 December 2024
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/NCT03838744.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing