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← Renal Cell Cancer

NCT01136733 · STUDY IN CONTEXT

A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth

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 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

A DLT was defined as either a treatment-related failure to administer greater than or equal to (\>=) 75% of the planned dosage of lenvatinib/everolimus or a specific National Cancer Institute Common Toxicity Criteria (NCI CTC) \>= Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care daily living activities) hematologic or nonhematologic toxicities considered to be possibly related to lenvatinib and/or everolimus therapy assessed during the first treatment cycle of each dose level. Higher grade indicates more severe toxicity.

Safety analysis set included all participants who received at least one dose of study treatment.

→

primary · POSTED

The highest dose level resulting in 0 or 1 DLT in 6 participants was to be considered the MTD of Phase 1b. Once the MTD was established, the participant cohort was expanded to a minimum of 10 participants. The MTD was confirmed by assessing DLTs during Cycle 1 and intolerable toxicities (i.e., not manageable with dose interruption and/or reduction) during Cycle 2 of therapy. Once the dose of lenvatinib/everolimus combination to be used in the succeeding Phase 2 part of the study was established, enrollment into Phase 2 was started. The RP2 dose was the same as the confirmed MTD and was used for the Phase 2 Treatment Arm A of this study.

Safety analysis set included all participants who received at least one dose of study treatment.

→

primary · POSTED

PFS was defined as the time (in months) from the date of first dose of study drug to the first documentation of disease progression or death, whichever occurred first. Kaplan-Meier (K-M) estimates were used to estimate median PFS, presented with 2-sided 95% confidence intervals (CIs). Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease using computed tomography (CT) or magnetic resonance imaging (MRI) and scan acquisition techniques (including use or nonuse of intravenous (IV) contrast). Tumor response was determined at the site by the investigator and radiologist using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in the evaluation of the tumor assessment scans. The date of objective disease progression was defined as the earliest date of radiological disease progression. Participants removed from therapy due to clinical progression with no radiologic confirmation were censored at their last radiologic assessment date.

Full analysis set included all randomized participants.

→

secondary · POSTED

OS was defined as the time (in months) from the date of randomization until date of death from any cause. Median survival time was calculated using K-M estimate for each treatment arm and presented with 2-sided 95% CIs. Participants who were lost to follow-up or alive at the data cutoff date (10 Dec 2014) were censored at the date the participants were last known to be alive.

Full analysis set which included all randomized participants.

→

secondary · POSTED

The ORR was defined as the percentage of participants who had the best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator, using RECIST 1.1 in the evaluation of MRI or CT scans of targeted lesions. Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease). The BOR was defined as the best response recorded from the start of the study treatment until discontinuation from the study. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR was calculated with exact 95% CIs using the method of Clopper and Pearson.

Full analysis set which included all randomized participants.

→

secondary · POSTED

The DCR was defined as the percentage of participants who had a BOR of CR or PR or SD (minimum duration from randomization to SD greater than or equal to 7 weeks). Assessments were performed every 8 weeks and were based on investigator review data using RECIST 1.1. The 95% CI was constructed using the method of Clopper and Pearson. DCR = CR + PR + SD greater than or equal to 7 weeks.

Full analysis set which included all randomized participants.

→

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
nct id
NCT01136733
trial label
A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth
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
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
7
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0000
    source section id
    NCT01136733-om-0000
    source outcome index
    0
    endpoint
    Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT)
    endpoint definition
    A DLT was defined as either a treatment-related failure to administer greater than or equal to (\>=) 75% of the planned dosage of lenvatinib/everolimus or a specific National Cancer Institute Common Toxicity Criteria (NCI CTC) \>= Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care daily living activities) hematologic or nonhematologic toxicities considered to be possibly related to lenvatinib and/or everolimus therapy assessed during the first treatment cycle of each dose level. Higher grade indicates more severe toxicity.
    time origin
    First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety analysis set included all participants who received at least one dose of study treatment.
    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
    nct id
    NCT01136733
    outcome key
    om-0001
    source section id
    NCT01136733-om-0001
    source outcome index
    1
    endpoint
    Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose
    endpoint definition
    The highest dose level resulting in 0 or 1 DLT in 6 participants was to be considered the MTD of Phase 1b. Once the MTD was established, the participant cohort was expanded to a minimum of 10 participants. The MTD was confirmed by assessing DLTs during Cycle 1 and intolerable toxicities (i.e., not manageable with dose interruption and/or reduction) during Cycle 2 of therapy. Once the dose of lenvatinib/everolimus combination to be used in the succeeding Phase 2 part of the study was established, enrollment into Phase 2 was started. The RP2 dose was the same as the confirmed MTD and was used for the Phase 2 Treatment Arm A of this study.
    time origin
    First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety analysis set included all participants who received at least one dose of study treatment.
    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
    nct id
    NCT01136733
    outcome key
    om-0002
    source section id
    NCT01136733-om-0002
    source outcome index
    2
    endpoint
    Phase 2: Progression-Free Survival (PFS)
    endpoint definition
    PFS was defined as the time (in months) from the date of first dose of study drug to the first documentation of disease progression or death, whichever occurred first. Kaplan-Meier (K-M) estimates were used to estimate median PFS, presented with 2-sided 95% confidence intervals (CIs). Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease using computed tomography (CT) or magnetic resonance imaging (MRI) and scan acquisition techniques (including use or nonuse of intravenous (IV) contrast). Tumor response was determined at the site by the investigator and radiologist using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in the evaluation of the tumor assessment scans. The date of objective disease progression was defined as the earliest date of radiological disease progression. Participants removed from therapy due to clinical progression with no radiologic confirmation were censored at their last radiologic assessment date.
    time origin
    Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set included all randomized participants.
    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
    nct id
    NCT01136733
    outcome key
    om-0003
    source section id
    NCT01136733-om-0003
    source outcome index
    3
    endpoint
    Phase 2: Overall Survival (OS)
    endpoint definition
    OS was defined as the time (in months) from the date of randomization until date of death from any cause. Median survival time was calculated using K-M estimate for each treatment arm and presented with 2-sided 95% CIs. Participants who were lost to follow-up or alive at the data cutoff date (10 Dec 2014) were censored at the date the participants were last known to be alive.
    time origin
    Randomization (Cycle 1 Day 1) until date of death from any cause, assessed up to the data cutoff date (10 Dec 2014), up to approximately 2 years and 9 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set which included all randomized participants.
    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
    nct id
    NCT01136733
    outcome key
    om-0004
    source section id
    NCT01136733-om-0004
    source outcome index
    4
    endpoint
    Phase 2: Objective Response Rate (ORR)
    endpoint definition
    The ORR was defined as the percentage of participants who had the best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator, using RECIST 1.1 in the evaluation of MRI or CT scans of targeted lesions. Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease). The BOR was defined as the best response recorded from the start of the study treatment until discontinuation from the study. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR was calculated with exact 95% CIs using the method of Clopper and Pearson.
    time origin
    Randomization (Cycle 1 Day 1) until first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set which included all randomized participants.
    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
    nct id
    NCT01136733
    outcome key
    om-0005
    source section id
    NCT01136733-om-0005
    source outcome index
    5
    endpoint
    Disease Control Rate (DCR)
    endpoint definition
    The DCR was defined as the percentage of participants who had a BOR of CR or PR or SD (minimum duration from randomization to SD greater than or equal to 7 weeks). Assessments were performed every 8 weeks and were based on investigator review data using RECIST 1.1. The 95% CI was constructed using the method of Clopper and Pearson. DCR = CR + PR + SD greater than or equal to 7 weeks.
    time origin
    Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set which included all randomized participants.
    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
    nct id
    NCT01136733
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus
    regimen
    Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2. If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus
    regimen
    Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
    analyzed count
    11
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus
    regimen
    Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus
    regimen
    The DLT was achieved and no participants were enrolled into this cohort.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus
    regimen
    Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0000
    arm key
    OG005
    arm label
    Phase 2 (Arm B): 24 mg Lenvatinib
    regimen
    Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0000
    arm key
    OG006
    arm label
    Phase 2 (Arm C): 10 mg Everolimus
    regimen
    Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0000#groups/OG006
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Phase 1b: Dose Escalation and MTD Expansion Cohorts
    regimen
    Oral everolimus (18 mg) and lenvatinib (5 mg) were taken once daily in the morning (consistently with or without food) with water. Any dietary habits around the time of study medication intake had to be kept as consistent as possible throughout the study.
    analyzed count
    11
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0001#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus
    regimen
    Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2. If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0002#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus
    regimen
    Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0002#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus
    regimen
    Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0002#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus
    regimen
    The DLT was achieved and no participants were enrolled into this cohort.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01136733-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    harm key
    EG000
    source section id
    NCT01136733-ae
    event group key
    EG000
    event group label
    Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus
    serious affected
    6
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.
    event definition
    Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.
    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
    nct id
    NCT01136733
    harm key
    EG001
    source section id
    NCT01136733-ae
    event group key
    EG001
    event group label
    Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus
    serious affected
    8
    serious at risk
    11
    other affected
    11
    other at risk
    11
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.
    event definition
    Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.
    undenominated note
    Source null
    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
    nct id
    NCT01136733
    harm key
    EG002
    source section id
    NCT01136733-ae
    event group key
    EG002
    event group label
    Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus
    serious affected
    0
    serious at risk
    2
    other affected
    2
    other at risk
    2
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.
    event definition
    Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.
    undenominated note
    Source null
    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
    nct id
    NCT01136733
    harm key
    EG003
    source section id
    NCT01136733-ae
    event group key
    EG003
    event group label
    Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.
    event definition
    Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.
    undenominated note
    Source null
    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
    nct id
    NCT01136733
    harm key
    EG004
    source section id
    NCT01136733-ae
    event group key
    EG004
    event group label
    Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus
    serious affected
    30
    serious at risk
    51
    other affected
    51
    other at risk
    51
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.
    event definition
    Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.
    undenominated note
    Source null
    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
    nct id
    NCT01136733
    harm key
    EG005
    source section id
    NCT01136733-ae
    event group key
    EG005
    event group label
    Phase 2 (Arm B): 24 mg Lenvatinib
    serious affected
    28
    serious at risk
    52
    other affected
    51
    other at risk
    52
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.
    event definition
    Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer
    nct id
    NCT01136733
    harm key
    EG006
    source section id
    NCT01136733-ae
    event group key
    EG006
    event group label
    Phase 2 (Arm C): 10 mg Everolimus
    serious affected
    21
    serious at risk
    50
    other affected
    50
    other at risk
    50
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.
    event definition
    Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.
    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