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← FOTIVDA: refractory Renal cell carcinoma after prior therapy

NCT02627963 · STUDY IN CONTEXT

A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)

Draft scope assessment: unclear. Attached because the study's own record describes refractory 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

The PFS, as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined 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.

Intent-to-treat (ITT) Population included all randomized participants.

→

secondary · POSTED

The OS is defined as the time from the date of randomization to date of death due to any cause.

ITT Population

→

secondary · POSTED

The ORR is defined as the percentage of participants who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).

ITT Population

→

secondary · POSTED

The DOR is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause.

ITT 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-fotivda-4b19deaf
nct id
NCT02627963
trial label
A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
applicability
unclear
applicability note
Attached because the study's own record describes refractory 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
4
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0000
    source section id
    NCT02627963-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    The PFS, as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined 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
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) Population included all randomized participants.
    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-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0001
    source section id
    NCT02627963-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    The OS is defined as the time from the date of randomization to date of death due to any cause.
    time origin
    Date of randomization to date of death (up to approximately 5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT 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-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0002
    source section id
    NCT02627963-om-0002
    source outcome index
    2
    endpoint
    Objective Response Rate (ORR)
    endpoint definition
    The ORR is defined as the percentage of participants who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).
    time origin
    Every 8 weeks from date of randomization until disease progression (up to approximately 5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT 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-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0003
    source section id
    NCT02627963-om-0003
    source outcome index
    3
    endpoint
    Duration of Response (DOR)
    endpoint definition
    The DOR is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause.
    time origin
    Assessed every 8 weeks from date of randomization until date of progression (up to approximately 5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT 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-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Tivozanib Hydrochloride
    regimen
    Participants randomized to this arm received the study drug, tivozanib hydrochloride.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02627963-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Sorafenib
    regimen
    Participants randomized to this arm received the comparator drug, sorafenib.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02627963-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Tivozanib Hydrochloride
    regimen
    Participants randomized to this arm received the study drug, tivozanib hydrochloride.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02627963-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Sorafenib
    regimen
    Participants randomized to this arm received the comparator drug, sorafenib.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02627963-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Tivozanib Hydrochloride
    regimen
    Participants randomized to this arm received the study drug, tivozanib hydrochloride.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02627963-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Sorafenib
    regimen
    Participants randomized to this arm received the comparator drug, sorafenib.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02627963-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Tivozanib Hydrochloride
    regimen
    Participants randomized to this arm received the study drug, tivozanib hydrochloride.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02627963-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Sorafenib
    regimen
    Participants randomized to this arm received the comparator drug, sorafenib.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02627963-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    harm key
    EG000
    source section id
    NCT02627963-ae
    event group key
    EG000
    event group label
    Tivozanib Hydrochloride
    serious affected
    81
    serious at risk
    173
    other affected
    171
    other at risk
    173
    frequency threshold
    5
    collection period
    From first dose to last dose plus 30 days (up to approximately 5 years)
    event definition
    Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
    undenominated 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-renal-cell-cancer-fotivda-4b19deaf
    nct id
    NCT02627963
    harm key
    EG001
    source section id
    NCT02627963-ae
    event group key
    EG001
    event group label
    Sorafenib
    serious affected
    67
    serious at risk
    170
    other affected
    170
    other at risk
    170
    frequency threshold
    5
    collection period
    From first dose to last dose plus 30 days (up to approximately 5 years)
    event definition
    Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
    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