A study about the effects of the drug Vorinostat (Zolinza) in patients with a previously treated, recurring special form of uterine cancer (sarcoma).

Phase 1

• Conditions: terine sarcoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000782-22-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-07
• Study Completion: 2018-07-06
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Safety and toxicity;Timepoint(s) of evaluation of this end point: Three, six, nine months