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← ALYMSYS: metastatic Renal cell carcinoma

NCT00410124 · STUDY IN CONTEXT

RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Suniti

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

Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the median PFS for each treatment group.

Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.

→

secondary · POSTED

Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group

Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.

→

secondary · POSTED

The Best Overall Response rate (BOR) is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.

Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.

→

secondary · POSTED

Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR). The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as the first documented progression or death. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.

Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.

→

secondary · POSTED

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.

Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.

→

secondary · POSTED

The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. There were 4 response categories (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much), sum of item responses can range from 0 to 36. "0"= severely symptomatic patient and the highest score is an asymptomatic patient. Definitive deterioration of the FKSI-DRS score was defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.

Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.

→

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

EORTC QLQ · Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-alymsys-7a90c80d
nct id
NCT00410124
qol key
qol-0004
source section id
NCT00410124-om-0004
source outcome index
4
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.
measure definition
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.
time frame
Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher score indicates better
population note
Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Time to Definitive Deterioration of the FKS-DRS Risk Score by at Least 2 Score Units Using Kaplan-Meier Method, by Treatment.

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-renal-cell-cancer-alymsys-7a90c80d
nct id
NCT00410124
qol key
qol-0005
source section id
NCT00410124-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fksi' in the study's own wording
scale title
Time to Definitive Deterioration of the FKS-DRS Risk Score by at Least 2 Score Units Using Kaplan-Meier Method, by Treatment.
measure definition
The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. There were 4 response categories (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much), sum of item responses can range from 0 to 36. "0"= severely symptomatic patient and the highest score is an asymptomatic patient. Definitive deterioration of the FKSI-DRS score was defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.
time frame
Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Time to Definitive Deterioration of the Physical Functioning Scale (PF)Score of the EORTC QLQ-C30 Questionnaire by at Least 10 Percent Using Kaplan_Meier Method, by Treatment.

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-renal-cell-cancer-alymsys-7a90c80d
nct id
NCT00410124
qol key
qol-0006
source section id
NCT00410124-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Definitive Deterioration of the Physical Functioning Scale (PF)Score of the EORTC QLQ-C30 Questionnaire by at Least 10 Percent Using Kaplan_Meier Method, by Treatment.
measure definition
The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Physical Functioning (PF) sub-scale, consisting of 5 questions each scored from 1 (not at all) to 4 (very much), and with possible values ranging from 5 to 20. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.
time frame
Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
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-renal-cell-cancer-alymsys-7a90c80d
nct id
NCT00410124
trial label
RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Suniti
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
3
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0000
    source section id
    NCT00410124-om-0000
    source outcome index
    0
    endpoint
    Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC
    endpoint definition
    Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the median PFS for each treatment group.
    time origin
    Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
    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
    NCT00410124
    outcome key
    om-0001
    source section id
    NCT00410124-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS) Assessed by the Monthly Overall Survival Assessments
    endpoint definition
    Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group
    time origin
    Assessed every month up to 2 years after the last patient was randomized into the study from the date of randomization to the time of death. (Data cutoff was 15Nov2009)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.
    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
    NCT00410124
    outcome key
    om-0002
    source section id
    NCT00410124-om-0002
    source outcome index
    2
    endpoint
    Best Overall Response Rate in Patients Who Receive RAD001 Plus BSC Versus Matching Placebo Plus BSC
    endpoint definition
    The Best Overall Response rate (BOR) is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.
    time origin
    Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.
    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
    NCT00410124
    outcome key
    om-0003
    source section id
    NCT00410124-om-0003
    source outcome index
    3
    endpoint
    Duration of Response in Patients Who Receive RAD001 Plus BSC Versus Placebo Plus BSC
    endpoint definition
    Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR). The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as the first documented progression or death. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.
    time origin
    Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
    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
    NCT00410124
    outcome key
    om-0004
    source section id
    NCT00410124-om-0004
    source outcome index
    4
    endpoint
    Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.
    endpoint definition
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.
    time origin
    Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
    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
    NCT00410124
    outcome key
    om-0005
    source section id
    NCT00410124-om-0005
    source outcome index
    5
    endpoint
    Time to Definitive Deterioration of the FKS-DRS Risk Score by at Least 2 Score Units Using Kaplan-Meier Method, by Treatment.
    endpoint definition
    The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. There were 4 response categories (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much), sum of item responses can range from 0 to 36. "0"= severely symptomatic patient and the highest score is an asymptomatic patient. Definitive deterioration of the FKSI-DRS score was defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.
    time origin
    Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
    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
    NCT00410124
    outcome key
    om-0000
    arm key
    OG000
    arm label
    RAD001 +BSC
    regimen
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0001
    arm key
    OG000
    arm label
    RAD001 +BSC
    regimen
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0002
    arm key
    OG000
    arm label
    RAD001 +BSC
    regimen
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0003
    arm key
    OG000
    arm label
    RAD001 +BSC
    regimen
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0004
    arm key
    OG000
    arm label
    RAD001 +BSC
    regimen
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0005
    arm key
    OG000
    arm label
    RAD001 +BSC
    regimen
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00410124-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    harm key
    EG000
    source section id
    NCT00410124-ae
    event group key
    EG000
    event group label
    Randomized to RAD001+ BSC ( Blinded + Open Label)
    serious affected
    135
    serious at risk
    274
    other affected
    261
    other at risk
    274
    frequency threshold
    5
    collection period
    Source null
    event definition
    The Safety population consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received.
    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-alymsys-7a90c80d
    nct id
    NCT00410124
    harm key
    EG001
    source section id
    NCT00410124-ae
    event group key
    EG001
    event group label
    Randomized to Placebo + BSC (Open Label)
    serious affected
    60
    serious at risk
    111
    other affected
    106
    other at risk
    111
    frequency threshold
    5
    collection period
    Source null
    event definition
    The Safety population consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received.
    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-alymsys-7a90c80d
    nct id
    NCT00410124
    harm key
    EG002
    source section id
    NCT00410124-ae
    event group key
    EG002
    event group label
    Randomized to Placebo + BSC (Double Blind Only)
    serious affected
    17
    serious at risk
    26
    other affected
    23
    other at risk
    26
    frequency threshold
    5
    collection period
    Source null
    event definition
    The Safety population consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received.
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00410124
    qol key
    qol-0004
    source section id
    NCT00410124-om-0004
    source outcome index
    4
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.
    measure definition
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.
    time frame
    Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher score indicates better
    population note
    Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
    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
    NCT00410124
    qol key
    qol-0005
    source section id
    NCT00410124-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'fksi' in the study's own wording
    scale title
    Time to Definitive Deterioration of the FKS-DRS Risk Score by at Least 2 Score Units Using Kaplan-Meier Method, by Treatment.
    measure definition
    The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. There were 4 response categories (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much), sum of item responses can range from 0 to 36. "0"= severely symptomatic patient and the highest score is an asymptomatic patient. Definitive deterioration of the FKSI-DRS score was defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.
    time frame
    Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
    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
    NCT00410124
    qol key
    qol-0006
    source section id
    NCT00410124-om-0006
    source outcome index
    6
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Definitive Deterioration of the Physical Functioning Scale (PF)Score of the EORTC QLQ-C30 Questionnaire by at Least 10 Percent Using Kaplan_Meier Method, by Treatment.
    measure definition
    The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Physical Functioning (PF) sub-scale, consisting of 5 questions each scored from 1 (not at all) to 4 (very much), and with possible values ranging from 5 to 20. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.
    time frame
    Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.
    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