Vorinostat (SAHA) in Uterine Sarcoma

Sponsor
Medical University of Graz
Study ID
NCT03509207
Phase
PHASE2
Status
Terminated

Conditions

  • Carcinosarcomas Uterine
  • Endometrial Stromal Tumors
  • Leiomyosarcoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat Oral Capsule — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 14, 2017
Status verified
Jul 2020
Primary completion
Feb 4, 2019
Completion
Feb 4, 2019

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat, Zolinza Oral Capsules
    Vorinostat Oral Capsules 400mg daily

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 9 months ]

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