NCT00390234 · STUDY IN CONTEXT

Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic 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 Response Rate, Evaluated According to the RECIST Criteria

Source null

→

primary · POSTED

Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)

Source null

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primary · POSTED

Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)

Source null

→

secondary · POSTED

Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.

Source null

→

secondary · POSTED

Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.

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-leiomyosarcoma
nct id: NCT00390234
trial label: Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic 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: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0000
source section id
NCT00390234-om-0000
source outcome index
0
endpoint
Objective Response Rate, Evaluated According to the RECIST Criteria
endpoint definition
Objective Response Rate, Evaluated According to the RECIST Criteria
time origin
Up to 3 years
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-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0001
source section id
NCT00390234-om-0001
source outcome index
1
endpoint
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)
endpoint definition
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)
time origin
6 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-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0003
source section id
NCT00390234-om-0003
source outcome index
3
endpoint
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)
endpoint definition
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)
time origin
6 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-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0002
source section id
NCT00390234-om-0002
source outcome index
2
endpoint
Survival (Leiomyosarcoma Group)
endpoint definition
Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.
time origin
Up to 3 years
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-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0004
source section id
NCT00390234-om-0004
source outcome index
4
endpoint
Survival (Carcinosarcoma Group)
endpoint definition
Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.
time origin
Up to 3 years
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-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0000
arm key
OG000
arm label
Treatment (Ziv-aflibercept)
regimen
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00390234-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0001
arm key
OG000
arm label
Treatment (Ziv-aflibercept)
regimen
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00390234-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0002
arm key
OG000
arm label
Treatment (Ziv-aflibercept)
regimen
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00390234-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0003
arm key
OG000
arm label
Treatment (Ziv-aflibercept)
regimen
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00390234-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00390234
outcome key
om-0004
arm key
OG000
arm label
Treatment (Ziv-aflibercept)
regimen
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00390234-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00390234
harm key
EG000
source section id
NCT00390234-ae
event group key
EG000
event group label
Treatment (Ziv-aflibercept)
serious affected
29
serious at risk
63
other affected
47
other at risk
63
frequency threshold
5
collection period
Source null
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