Trial Outcomes & Findings for Vorinostat (SAHA) in Uterine Sarcoma (NCT NCT03509207)

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

9 months

Results posted on

2020-08-04

Participant Flow

3 patients were enrolled. The study was prematurely closed due to the sluggish patient recruitment and the difficult acquisition of the investigational product.

There were no Screening failures in the Course of the study.

Participant milestones

Participant milestones
Measure	Vorinostat, Zolinza Oral Capsules Vorinostat Oral Capsules 400mg daily 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.
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Vorinostat, Zolinza Oral Capsules Vorinostat Oral Capsules 400mg daily 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.
Overall Study Death	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorinostat, Zolinza Oral Capsules n=3 Participants Vorinostat Oral Capsules 400mg daily 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.
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants
Sex: Female, Male Female	3 Participants n=3 Participants
Sex: Female, Male Male	0 Participants n=3 Participants
Region of Enrollment Austria	3 participants n=3 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Only one Patient reached the first end Point. Statistical Evaluation was therefore not possible. For this reason no data are reported in the data table.

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Only one Patient reached the first end Point. Statistical Evaluation was therefore not possible. For this reason no data are reported in the data table.

This endpoint is evaluated by the amount of clinical adverse experiences.

Outcome measures

Outcome data not reported

Adverse Events

Vorinostat, Zolinza Oral Capsules

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Vorinostat, Zolinza Oral Capsules n=3 participants at risk Vorinostat Oral Capsules 400mg daily 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.
Reproductive system and breast disorders Death of uterine carcinoma	66.7% 2/3 • Number of events 2 • From enrolment to study completion per Patient, up to 41 weeks.
Respiratory, thoracic and mediastinal disorders pleural effusion	66.7% 2/3 • Number of events 2 • From enrolment to study completion per Patient, up to 41 weeks.
Reproductive system and breast disorders abscess of the vaginal vault	33.3% 1/3 • Number of events 1 • From enrolment to study completion per Patient, up to 41 weeks.

Other adverse events

Adverse event data not reported

Additional Information

Prof. Edgar Petru

Medical University of Graz

Phone: 0043 31638581082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place