TriangleNCT03509207 · STUDY IN CONTEXT
Vorinostat (SAHA) in Uterine Sarcoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-leiomyosarcoma
- nct id
- NCT03509207
- trial label
- Vorinostat (SAHA) in Uterine Sarcoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 2
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-leiomyosarcoma
- nct id
- NCT03509207
- outcome key
- om-0000
- source section id
- NCT03509207-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- 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)
- time origin
- 9 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-leiomyosarcoma
- nct id
- NCT03509207
- outcome key
- om-0001
- source section id
- NCT03509207-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
- endpoint definition
- This endpoint is evaluated by the amount of clinical adverse experiences.
- time origin
- 9 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-leiomyosarcoma
- nct id
- NCT03509207
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Vorinostat, Zolinza Oral Capsules
- regimen
- 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.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03509207-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-leiomyosarcoma
- nct id
- NCT03509207
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Vorinostat, Zolinza Oral Capsules
- regimen
- 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.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03509207-om-0001#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-leiomyosarcoma
- nct id
- NCT03509207
- harm key
- EG000
- source section id
- NCT03509207-ae
- event group key
- EG000
- event group label
- Vorinostat, Zolinza Oral Capsules
- serious affected
- 2
- serious at risk
- 3
- other affected
- 0
- other at risk
- 3
- frequency threshold
- 5
- collection period
- From enrolment to study completion per Patient, up to 41 weeks.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice