NCT00112463 · STUDY IN CONTEXT

Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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 tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR

Participants who were evaluable for response

→

primary · POSTED

Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is the number of months from first treatment until the date of progression.

All treated participants

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primary · POSTED

The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study. A summary of the individual toxicities can be found in the AE/SAE results.

All treated participants

→

secondary · POSTED

Months from first treatment until death or the last date of contact

All treated participants

→

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-gastrointestinal-stromal-tumors
nct id: NCT00112463
trial label: Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT00112463
outcome key
om-0000
source section id
NCT00112463-om-0000
source outcome index
0
endpoint
Objective Tumor Response (Complete and Partial)
endpoint definition
Objective tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR
time origin
While on treatment - max of 16 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who were evaluable for 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-gastrointestinal-stromal-tumors
nct id
NCT00112463
outcome key
om-0001
source section id
NCT00112463-om-0001
source outcome index
1
endpoint
Time to Progression
endpoint definition
Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is the number of months from first treatment until the date of progression.
time origin
Until disease progression - max of 48 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants
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-gastrointestinal-stromal-tumors
nct id
NCT00112463
outcome key
om-0002
source section id
NCT00112463-om-0002
source outcome index
2
endpoint
Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3
endpoint definition
The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study. A summary of the individual toxicities can be found in the AE/SAE results.
time origin
During treatment (max of 16 months) and for 1 month following treatment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants
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-gastrointestinal-stromal-tumors
nct id
NCT00112463
outcome key
om-0003
source section id
NCT00112463-om-0003
source outcome index
3
endpoint
Survival
endpoint definition
Months from first treatment until death or the last date of contact
time origin
Max of 98 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants
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-gastrointestinal-stromal-tumors
nct id
NCT00112463
outcome key
om-0000
arm key
OG000
arm label
Treatment (Single-agent Depsipeptide)
regimen
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
analyzed count
35
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112463-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT00112463
outcome key
om-0001
arm key
OG000
arm label
Treatment (Single-agent Depsipeptide)
regimen
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112463-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT00112463
outcome key
om-0002
arm key
OG000
arm label
Treatment (Single-agent Depsipeptide)
regimen
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. romidepsin: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112463-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT00112463
outcome key
om-0003
arm key
OG000
arm label
Treatment (Single-agent Depsipeptide)
regimen
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112463-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT00112463
harm key
EG000
source section id
NCT00112463-ae
event group key
EG000
event group label
Treatment (Single-agent Depsipeptide)
serious affected
13
serious at risk
38
other affected
38
other at risk
38
frequency threshold
5
collection period
During treatment (max of 16 months) and for 1 month following treatment
event definition
Toxicities were evaluated weekly while the participant was on treatment
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