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 range18 Years
SexFEMALE
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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 …