NCT03509207 · REGISTRY CONDITION SEARCH

Vorinostat (SAHA) in Uterine Sarcoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2020-08-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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 or similar medications * 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- * Prior history of thrombotic or thromboembolic events, unless adequately controlled by anticoagulant therapy
gender Based: true
gender Description: The investigated condition occurs exclusively in women
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Vorinostat Oral Capsules 400mg daily
intervention Names
Drug: Vorinostat Oral Capsule
label
Vorinostat, Zolinza Oral Capsules
type
EXPERIMENTAL

interventions

arm Group Labels
Vorinostat, Zolinza Oral Capsules
description
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.
name
Vorinostat Oral Capsule
other Names
Zolinza
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 3
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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)
measure
Progression-free Survival (PFS)
time Frame
9 months

secondary Outcomes

description
This endpoint is evaluated by the amount of clinical adverse experiences.
measure
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
time Frame
9 months

Full study description

brief 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.
detailed Description: This is an open-label, single arm, proof of concept-study of the HDAC-inhibitor vorinostat in patients with refractory uterine sarcoma that have been pre-tested for an high expression of HDAC. Patients will receive Vorinostat, 400 mg (4 capsules á 100mg of Zolinza) orally once daily for the first 14 days of a 21 day cycle. Treatment will be continued for 4 cycles (treatment period 1). Patients with a response or stable disease after 4 cycles as determined by computed tomography (CT) of target an non target-lesions 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 9 months period (treatment periods 2 and 3).

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
edge id
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exact text
NCT03509207
start
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offset unit
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query cond
Uterine Sarcoma
query disease state id
ds-uterine-sarcoma
source file
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice