Vorinostat (SAHA) in Uterine Sarcoma
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|ClinicalTrials.gov Identifier: NCT03509207|
Recruitment Status : Terminated (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)
First Posted : April 26, 2018
Results First Posted : July 27, 2020
Last Update Posted : August 4, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Leiomyosarcoma Endometrial Stromal Tumors Carcinosarcomas Uterine||Drug: Vorinostat Oral Capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Peroral Vorinostat (SAHA) in Patients With Refractory Histone Deacetylase-positive Uterine Sarcoma|
|Actual Study Start Date :||December 14, 2017|
|Actual Primary Completion Date :||February 4, 2019|
|Actual Study Completion Date :||February 4, 2019|
Experimental: Vorinostat, Zolinza Oral Capsules
Vorinostat Oral Capsules 400mg daily
Drug: Vorinostat Oral Capsule
Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles 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 period of 9 months.
Other Name: Zolinza
- Progression-free Survival (PFS) [ Time Frame: 9 months ]Change from Baseline Tumor Size to last available observation with respect to progress as defined by RECIST 1.1 (CT-Scan every 12 weeks up to 9 months)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 9 months ]This endpoint is evaluated by the amount of clinical adverse experiences.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509207
|Medical University of Graz, Clinic of Obstetrics and Gynecology|
|Graz, Austria, 8036|
|Principal Investigator:||Edgar Petru, MD||Department of OB/GYN of the Medical University of Graz|