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← recurrent Malignant Mesothelioma

NCT00309946 · STUDY IN CONTEXT

Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery

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

Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.

Source null

→

secondary · POSTED

Examined using paired t-test or Wilcoxon signed-ranks test.

This outcome was not measured/assessed for any of the study subjects.

→

secondary · POSTED

Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.

This outcome was not measured/assessed for any of the study subjects.

→

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

FACT · Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT00309946
qol key
qol-0002
source section id
NCT00309946-om-0002
source outcome index
2
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity
measure definition
Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.
time frame
Week 1 of course 1
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
This outcome was not measured/assessed for any of the study subjects.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma-recurrent-f0c1024d
nct id
NCT00309946
trial label
Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
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
3
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT00309946
    outcome key
    om-0000
    source section id
    NCT00309946-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate, Complete (CR) or Partial (PR) Response
    endpoint definition
    Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
    time origin
    Every 8 weeks
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT00309946
    outcome key
    om-0001
    source section id
    NCT00309946-om-0001
    source outcome index
    1
    endpoint
    Changes in Laboratory Correlates
    endpoint definition
    Examined using paired t-test or Wilcoxon signed-ranks test.
    time origin
    Baseline, days 15 and 29 of course 1, and then every 28 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome was not measured/assessed for any of the study subjects.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT00309946
    outcome key
    om-0002
    source section id
    NCT00309946-om-0002
    source outcome index
    2
    endpoint
    Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity
    endpoint definition
    Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.
    time origin
    Week 1 of course 1
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome was not measured/assessed for any of the study subjects.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT00309946
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309946-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT00309946
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309946-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT00309946
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Enzyme Inhibitor Therapy)
    regimen
    Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309946-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT00309946
    harm key
    EG000
    source section id
    NCT00309946-ae
    event group key
    EG000
    event group label
    Treatment (Enzyme Inhibitor Therapy)
    serious affected
    31
    serious at risk
    51
    other affected
    49
    other at risk
    51
    frequency threshold
    5
    collection period
    After completion of study treatment, patients are followed for up to 8 weeks.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-mesothelioma-recurrent-f0c1024d
    nct id
    NCT00309946
    qol key
    qol-0002
    source section id
    NCT00309946-om-0002
    source outcome index
    2
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity
    measure definition
    Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.
    time frame
    Week 1 of course 1
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    This outcome was not measured/assessed for any of the study subjects.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice