Vorinostat (SAHA) in Uterine Sarcoma (NCT03509207) | Clinical Trial Compass
TerminatedPhase 2
Vorinostat (SAHA) in Uterine Sarcoma
Stopped: 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
Austria3 participantsStarted 2017-12-14
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.