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NCT03509207
Vorinostat (SAHA) in Uterine Sarcoma
Phase 2 trial testing Vorinostat Oral Capsule in Leiomyosarcoma in 3 participants. Terminated before completion.
4 February 2019
Quick facts
| Lead sponsor | Medical University of Graz |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 14 December 2017 |
| Primary completion | 4 February 2019 |
| Estimated completion | 4 February 2019 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Vorinostat Oral Capsule — full drug profile →
Conditions studied
- Leiomyosarcoma — all drugs for Leiomyosarcoma →
- Endometrial Stromal Tumors — all drugs for Endometrial Stromal Tumors →
- Carcinosarcomas Uterine — all drugs for Carcinosarcomas Uterine →
Sponsor
Medical University of Graz
Who can join
18 and older, female only, with Leiomyosarcoma or Endometrial Stromal Tumors. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: From enrolment to study completion per Patient, up to 41 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (3 terms)
| Reaction | System | Vorinostat, Zolinza Oral C… |
|---|---|---|
| Death of uterine carcinoma | Reproductive system and breast disorders | — |
| pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| abscess of the vaginal vault | Reproductive system and breast disorders | — |
Most-reported serious reactions: Death of uterine carcinoma, pleural effusion, abscess of the vaginal vault.
Data from ClinicalTrials.gov NCT03509207 adverse events section.
Sponsor's own description
Uterine sarcomas are rare tumors with a poor prognosis. The main purpose of this phase II proof-of-principle- pilot study is to test the efficacy of the hydroxamic acid-based Histone deacetylase inhibitor (HDACI) Vorinostat (SAHA) as monotherapy in patients with HDAC-positive, progressive, metastatic uterine sarcomas and mixed epithelial and mesenchymal tumors after prior anti-proliferative therapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comprehensive Review of Uterine Leiomyosarcoma: Pathogenesis, Diagnosis, Prognosis, and Targeted Therapy.
Yang Q, Madueke-Laveaux OS, Cun H, Wlodarczyk M, et al · · 2024 · cited 24× · PMID 38994959 · DOI 10.3390/cells13131106 -
HDAC Inhibition Induces Cell Cycle Arrest and Mesenchymal-Epithelial Transition in a Novel Pleural-Effusion Derived Uterine Carcinosarcoma Cell Line.
Stockhammer P, Okumus Ö, Hegedus L, Rittler D, et al · · 2021 · cited 9× · PMID 34257602 · DOI 10.3389/pore.2021.636088
Verify or expand the search:
- PubMed search for NCT03509207
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Leiomyosarcoma
Currently open trials in the same condition.
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- NCT06528769 — Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma · Phase 2 · recruiting
- NCT06975293 — STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants · Phase 1, PHASE2 · recruiting
- NCT06849986 — IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS) · Phase 2 · recruiting
- NCT06308419 — A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcoma · Phase 1 · recruiting
Other Medical University of Graz trials
Trials by the same sponsor.
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- NCT07492823 — Clinical Applicability of Liquid Biopsy in Chondrosarcoma · not yet recruiting
- NCT07297615 — 3D Liver Volumetry · NA · not yet recruiting
- NCT07588282 — The Effect of Psychoeducational Diagnosis Communication on Perception of Illness, Satisfaction, and Behavioral Intention · NA · recruiting
- NCT07376096 — Liquid Biopsy in Germ Cell Tumors · not yet 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 NCT03509207 (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 Medical University of Graz
- Last refreshed: 4 August 2020
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/NCT03509207.
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