Vorinostat (SAHA) in Uterine Sarcoma


Medical University of Graz

Status and phase

Phase 2


Carcinosarcomas Uterine
Endometrial Stromal Tumors


Drug: Vorinostat Oral Capsule

Study type


Funder types



Details and patient eligibility


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.

Full description

This is an open-label, single arm, proof of concept-study of the HDAC-inhibitor vorinostat in patients with refractory uterine sarcoma that have been pre-tested for an high expression of HDAC. Patients will receive Vorinostat, 400 mg (4 capsules á 100mg of Zolinza) orally once daily for the first 14 days of a 21 day cycle. Treatment will be continued for 4 cycles (treatment period 1). Patients with a response or stable disease after 4 cycles as determined by computed tomography (CT) of target an non target-lesions will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a 9 months period (treatment periods 2 and 3).


3 patients




18+ years old


No Healthy Volunteers

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

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

3 participants in 1 patient group

Vorinostat, Zolinza Oral Capsules
Experimental group
Vorinostat Oral Capsules 400mg daily
Drug: Vorinostat Oral Capsule

Trial documents

Trial contacts and locations



Data sourced from

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