NCT00659360 · STUDY IN CONTEXT

AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic 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

Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Source null

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secondary · POSTED

Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions

Source null

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secondary · POSTED

Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.

Source null

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secondary · POSTED

Achieved stable disease as their best response

Source null

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secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Tumor Response "of more than 4 months" was counted toward the Disease Control Rate.

Patients who had partial response, complete response or stable disease

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secondary · POSTED

The Kaplan-Meier method will be used to estimate time to progression estimates. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Source null

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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: NCT00659360
trial label: AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic 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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00659360
outcome key
om-0000
source section id
NCT00659360-om-0000
source outcome index
0
endpoint
Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.
endpoint definition
Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
time origin
Up to 5 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
NCT00659360
outcome key
om-0001
source section id
NCT00659360-om-0001
source outcome index
1
endpoint
Objective Response Rate
endpoint definition
Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
time origin
Up to 5 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
NCT00659360
outcome key
om-0002
source section id
NCT00659360-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.
time origin
Up to 5 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
NCT00659360
outcome key
om-0003
source section id
NCT00659360-om-0003
source outcome index
3
endpoint
Stable Disease Rate
endpoint definition
Achieved stable disease as their best response
time origin
Up to 5 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
NCT00659360
outcome key
om-0004
source section id
NCT00659360-om-0004
source outcome index
4
endpoint
Duration of Response
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Tumor Response "of more than 4 months" was counted toward the Disease Control Rate.
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who had partial response, complete response or stable disease
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
NCT00659360
outcome key
om-0005
source section id
NCT00659360-om-0005
source outcome index
5
endpoint
Time to Disease Progression
endpoint definition
The Kaplan-Meier method will be used to estimate time to progression estimates. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
time origin
Up to 5 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
NCT00659360
outcome key
om-0000
arm key
OG000
arm label
Arm I
regimen
Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00659360-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00659360
outcome key
om-0001
arm key
OG000
arm label
Arm I
regimen
Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00659360-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00659360
outcome key
om-0002
arm key
OG000
arm label
Arm I
regimen
Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00659360-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00659360
outcome key
om-0003
arm key
OG000
arm label
Arm I
regimen
Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00659360-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00659360
outcome key
om-0004
arm key
OG000
arm label
Arm I AZD0530
regimen
Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00659360-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00659360
outcome key
om-0005
arm key
OG000
arm label
Arm I
regimen
Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00659360-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT00659360
harm key
EG000
source section id
NCT00659360-ae
event group key
EG000
event group label
Arm I
serious affected
5
serious at risk
17
other affected
17
other at risk
17
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