Uterine sarcoma
Conditions
Interventions
Trade Name: Zolinza
Product Name: Zolinza
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Vorinostat
CAS Number: 149647-78-9
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of metastatic uterine sarcoma - High HDAC-positivity of the tumor determined by IHC - Prior systemic antineoplastic therapy for metastatic disease -Patient not amenable for curative therapy - Women, age >= 18 years - Life expectancy > 3 months - Measurable (> 1cm) or non-measurable (but radiologically evaluable) disease per RECIST version 1.1 on computed tomography (CT) scan or MRT scan? - Karnofsky performance status of 60-100 - Written informed consent - Subject is able to swallow and retain oral medication and does not have uncontrolled emesis - Adequate bone marrow reserve, liver and kidney function - Adequate hematologic, renal and hepatic function - No fertility preserved Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - Lack of or low expression of HDAC of the tumor determined by IHC - 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 active infection - Known HIV-positivity - Symptomatic brain metastasis or leptomeningeal disease - Pre-existing liver disease, severe hepatic impairment (Bilirubin no greater than 1.5 times upper limit of normal (ULN) and/or AST/ALT greater than 2.5 times ULN - Known history of allergic reaction to vorinostat or similar medications - Received 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Progression-free survival (PFS) at 3, 6 and 9 months;Timepoint(s) of evaluation of this end point: Three, six and nine months;Main Objective: The main purpose is to test the efficacy of the hydroxamic acid-based HDAC inhibitor Vorinostat as monotherapy in patients with histone deacetylase-positive, progressive, metastatic uterine sarcomas after prior anti-proliferative therapy.;Secondary Objective: Evaluation of safety and toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and toxicity;Timepoint(s) of evaluation of this end point: Three, six, nine months | — |
Countries
Austria
Contacts
Public ContactTrial Center
Medical University of Graz, Department of Obstetrics and Gynecology
Outcome results
None listed