NCT00243074 · STUDY IN CONTEXT
S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
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
confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. 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
The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.
The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.
Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment. See adverse event tables for specific details.
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-malignant-mesothelioma
- nct id
- NCT00243074
- trial label
- S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
- 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-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0000
- source section id
- NCT00243074-om-0000
- source outcome index
- 0
- endpoint
- Overall Response Rate
- endpoint definition
- confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
- time origin
- Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who received any amount of AZD2171
- 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-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0001
- source section id
- NCT00243074-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
- time origin
- Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who received AZD2171
- 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-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0002
- source section id
- NCT00243074-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival
- endpoint definition
- From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. 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
- Every 8 weeks until disease progression or death, up to 5 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who received AZD2171
- 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-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0003
- source section id
- NCT00243074-om-0003
- source outcome index
- 3
- endpoint
- Disease Control Rate
- endpoint definition
- The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.
- time origin
- Every 8 weeks until disease progression progression, up to 5 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who received AZD2171
- 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-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0004
- source section id
- NCT00243074-om-0004
- source outcome index
- 4
- endpoint
- Objective Response Rate Per Modified RECIST for Pleural Tumors
- endpoint definition
- The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.
- time origin
- Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who received any amount of AZD2171
- 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-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0005
- source section id
- NCT00243074-om-0005
- source outcome index
- 5
- endpoint
- Adverse Event Rates
- endpoint definition
- Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment. See adverse event tables for specific details.
- time origin
- Daily during protocol treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who received protocol treatment were assessed for adverse events. See adverse event tables for specific details.
- 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-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0000
- arm key
- OG000
- arm label
- AZD2171 (Cediranib Maleate)
- regimen
- AZD2171 (Cediranib Maleate)
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00243074-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0001
- arm key
- OG000
- arm label
- AZD2171
- regimen
- AZD2171
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00243074-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0002
- arm key
- OG000
- arm label
- AZD2171
- regimen
- AZD2171
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00243074-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0003
- arm key
- OG000
- arm label
- AZD2171
- regimen
- AZD2171
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00243074-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0004
- arm key
- OG000
- arm label
- AZD2171
- regimen
- AZD2171
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00243074-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00243074
- outcome key
- om-0005
- arm key
- OG000
- arm label
- AZD2171 (Cediranib Maleate)
- regimen
- AZD2171 (Cediranib Maleate)
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00243074-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00243074
- harm key
- EG000
- source section id
- NCT00243074-ae
- event group key
- EG000
- event group label
- AZD2171
- serious affected
- 22
- serious at risk
- 47
- other affected
- 42
- other at risk
- 47
- frequency threshold
- 5
- collection period
- Daily during protocol treatment.
- 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
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