Clinical trial · Interventional
Vorinostat (SAHA) in Uterine Sarcoma
A Pilot Study of Peroral Vorinostat (SAHA) in Patients With Refractory Histone Deacetylase-positive Uterine Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The early termination was NOT due to safety reasons, terminated because of the very slow recruitment and problematic access to the study medication in Europe
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinosarcomas Uterine | — | UNRESOLVED | — |
| Endometrial Stromal Tumors | — | UNRESOLVED | — |
| Leiomyosarcoma | Leiomyosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vorinostat Oral Capsule | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vorinostat, Zolinza Oral Capsules
- description
- Vorinostat Oral Capsules 400mg daily
- interventionNames
- Drug: Vorinostat Oral Capsule
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- 9 months
- description
- Change from Baseline Tumor Size to last available observation with respect to progress as defined by RECIST 1.1 (CT-Scan every 12 weeks up to 9 months)
Secondary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
- timeFrame
- 9 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic uterine sarcoma (endometrial stromal sarcoma, undifferentiated uterine sarcoma, leiomyosarcoma, adenosarcoma and carcinosarcoma * High HDAC-positivity of the tumor determined by immunohistochemistry * Patients must have received prior systemic antineoplastic therapy * Patient is not amenable for curative therapy * Age \>= 18 years * Estimated life expectancy \> 3 months * Measurable disease on CT/MRI (at least one measurable lesion \>1cm) or chest X-ray (at least one measurable lesion \>2cm) * Karnofsky performance status of 60-100 * Adequate hematologic, renal and hepatic function * Subject is able to swallow and retain oral medication and does not have uncontrolled emesis * No fertility preserved * Written informed consent Exclusion Criteria: * Lack of or low expression of HDAC (see 4.1 "Pre-Screening") * Significant cardiac disease * Other invasive malignant tumor diagnosed within the last 5 years (e.g. metastases from breast cancer in the last 3 years) * Significant bowel obstruction * Severe uncontrolled infection * Known HIV-positivity * Symptomatic brain metastasis or leptomeningeal disease * Pre-existing significant liver disease, severe hepatic impairment (Bilirubin no greater than 1.5 times upper limit of normal (ULN) and/or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) greater than 2.5 times ULN) * Known history of allergic reaction to vorinostat or similar medications * Systemic therapy or an investigational agent within 21 days prior to study inclusion * Uncontrolled hypertension (sustained systolic blood pressure \> 150 mmHg or diastolic pressure \> 100 mmHg despite optimal medical management) * Major surgery within 3 weeks of enrollment when diagnosed at an early stage * Symptomatic congestive heart failure * Unstable angina pectoris or cardiac arrhythmia * Myocardial infarction within last 6 months * Known active hepatitis B or hepatitis C * Psychiatric illness/social situations that would limit compliance with study requirements- * Prior history of thrombotic or thromboembolic events, unless adequately controlled by anticoagulant therapy
References
Publications (0)
Data not yet available