NCT01175980 · STUDY IN CONTEXT

Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Objective (Best) response according to RECIST 1.1 criteria.

Source null

→

secondary · POSTED

Toxicity will be tabulated via frequency distributions, and also dichotomized to report the proportion (and percentage) of patients experiencing a specified level (e.g., grade 3-4) of toxicity.

Source null

→

secondary · POSTED

TTR will be summarized descriptively, reporting N, median, mean, standard deviation, standard error (SE), minimum, maximum, and 90% CI for the mean calculated from the SE and asymptotic normal distribution theory.

Only 2 patients achieved a response.

→

secondary · POSTED

Median point estimate and full range will be documented, since only two patients achieved a response.

Only 2 patients achieved a response.

→

secondary · POSTED

Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both median point estimate and 90% confidence interval (CI) estimate.

Source null

→

secondary · POSTED

Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both point and 90% CI estimates of various statistics of interest can be calculated (e.g., median, 6-month event-free rate, 12-month event-free rate, etc.). Statistical graphs of each K-M curve (with 90% CI lines) will be generated for visual display. (One year survival rate will be given since OS median was not reached due to too few events)

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-salivary-gland-cancer-recurrent-79ac7906
nct id: NCT01175980
trial label: Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0000
source section id
NCT01175980-om-0000
source outcome index
0
endpoint
Objective Response According to RECIST 1.1 Criteria
endpoint definition
Objective (Best) response according to RECIST 1.1 criteria.
time origin
Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0001
source section id
NCT01175980-om-0001
source outcome index
1
endpoint
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
endpoint definition
Toxicity will be tabulated via frequency distributions, and also dichotomized to report the proportion (and percentage) of patients experiencing a specified level (e.g., grade 3-4) of toxicity.
time origin
Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0002
source section id
NCT01175980-om-0002
source outcome index
2
endpoint
Time to Recurrence (TTR)
endpoint definition
TTR will be summarized descriptively, reporting N, median, mean, standard deviation, standard error (SE), minimum, maximum, and 90% CI for the mean calculated from the SE and asymptotic normal distribution theory.
time origin
From the start of the treatment until the RECIST measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded, assessed up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only 2 patients achieved a response.
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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0003
source section id
NCT01175980-om-0003
source outcome index
3
endpoint
Response Duration (RD)
endpoint definition
Median point estimate and full range will be documented, since only two patients achieved a response.
time origin
From the time measurement criteria are met for CR or PR (whichever is first) until the first date that recurrence or progression is objectively documented, assessed up to 60 months after the last dose of vorinostat max. treatment duration= 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only 2 patients achieved a response.
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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0004
source section id
NCT01175980-om-0004
source outcome index
4
endpoint
Progression-free Survival (PFS)
endpoint definition
Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both median point estimate and 90% confidence interval (CI) estimate.
time origin
From start of treatment to time of progression or death, whichever occurs first, assessed up to 60 months after the last dose of vorinostat maximum treatment duration= 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0005
source section id
NCT01175980-om-0005
source outcome index
5
endpoint
Overall Survival (OS)
endpoint definition
Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both point and 90% CI estimates of various statistics of interest can be calculated (e.g., median, 6-month event-free rate, 12-month event-free rate, etc.). Statistical graphs of each K-M curve (with 90% CI lines) will be generated for visual display. (One year survival rate will be given since OS median was not reached due to too few events)
time origin
From the start of treatment until death from any cause, duration for reported probability= 1 year; survival data collected for up to a total of 60 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0000
arm key
OG000
arm label
Treatment (Vorinostat)
regimen
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01175980-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0001
arm key
OG000
arm label
Treatment (Vorinostat)
regimen
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01175980-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0002
arm key
OG000
arm label
Treatment (Vorinostat)
regimen
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01175980-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0003
arm key
OG000
arm label
Treatment (Vorinostat)
regimen
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01175980-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0004
arm key
OG000
arm label
Treatment (Vorinostat)
regimen
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01175980-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
outcome key
om-0005
arm key
OG000
arm label
Treatment (Vorinostat)
regimen
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01175980-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01175980
harm key
EG000
source section id
NCT01175980-ae
event group key
EG000
event group label
Treatment (Vorinostat)
serious affected
20
serious at risk
30
other affected
30
other at risk
30
frequency threshold
0
collection period
From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
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