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← ALYMSYS: metastatic Renal cell carcinoma

NCT00387764 · STUDY IN CONTEXT

Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.

All Treated Participants (ATP) Population: all enrolled participants who received at least one dose of open-label investigational product

→

primary · POSTED

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the NCI CTCAE, version 3.0: Grade 1, mild; Grade 2, moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling; Grade 5, death.

ATP Population

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primary · POSTED

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The investigator assessed relatedness between the AE and the investigational product.

ATS Population

→

primary · POSTED

The time on investigational product (including dose interruptions) is defined as the difference between the date of the last dose of investigational product and the date of the first dose of investigational product plus one.

ATS Population

→

primary · POSTED

Clinical chemistry parameters were summarized according to NCI CTCAE, version 4.0: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.

ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.

→

primary · POSTED

Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC \[leukopenia\]), and prothrombin time international normalized ratio (PT \[INR\]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.

ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.

→

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-renal-cell-cancer-alymsys-7a90c80d
nct id
NCT00387764
trial label
Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic 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
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0000
    source section id
    NCT00387764-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
    endpoint definition
    An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.
    time origin
    From Baseline to Follow-up (up to 6.230 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All Treated Participants (ATP) Population: all enrolled participants who received at least one dose of open-label investigational product
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0001
    source section id
    NCT00387764-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)
    endpoint definition
    An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the NCI CTCAE, version 3.0: Grade 1, mild; Grade 2, moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling; Grade 5, death.
    time origin
    From Baseline to Follow-up (up to 6.230 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ATP Population
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0002
    source section id
    NCT00387764-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Adverse Events Related to Investigational Product
    endpoint definition
    An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The investigator assessed relatedness between the AE and the investigational product.
    time origin
    From Baseline to Follow-up (up to 6.230 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ATS Population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0003
    source section id
    NCT00387764-om-0003
    source outcome index
    3
    endpoint
    Median Time on Investigational Product
    endpoint definition
    The time on investigational product (including dose interruptions) is defined as the difference between the date of the last dose of investigational product and the date of the first dose of investigational product plus one.
    time origin
    From Baseline to investigational product discontinuation (up to 6.230 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ATS Population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0004
    source section id
    NCT00387764-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
    endpoint definition
    Clinical chemistry parameters were summarized according to NCI CTCAE, version 4.0: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.
    time origin
    From Baseline to investigational product discontinuation (up to 6.230 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0005
    source section id
    NCT00387764-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
    endpoint definition
    Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC \[leukopenia\]), and prothrombin time international normalized ratio (PT \[INR\]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.
    time origin
    From Baseline to investigational product discontinuation (up to 6.230 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pazopanib 800 mg
    regimen
    Participants received pazopanib 800 milligrams (mg) once daily.
    analyzed count
    80
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00387764-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pazopanib 800 mg
    regimen
    Participants received pazopanib 800 milligrams (mg) once daily.
    analyzed count
    80
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00387764-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pazopanib 800 mg
    regimen
    Participants received pazopanib 800 milligrams (mg) once daily.
    analyzed count
    80
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00387764-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pazopanib 800 mg
    regimen
    Participants received pazopanib 800 milligrams (mg) once daily.
    analyzed count
    80
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00387764-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Pazopanib 800 mg
    regimen
    Participants received pazopanib 800 milligrams (mg) once daily.
    analyzed count
    80
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00387764-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Pazopanib 800 mg
    regimen
    Participants received pazopanib 800 milligrams (mg) once daily.
    analyzed count
    80
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00387764-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00387764
    harm key
    EG000
    source section id
    NCT00387764-ae
    event group key
    EG000
    event group label
    Pazopanib 800 mg
    serious affected
    27
    serious at risk
    80
    other affected
    72
    other at risk
    80
    frequency threshold
    5
    collection period
    Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
    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