Trial · NCT00419159
Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy
NCT00419159, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2011-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy. Trials, record NCT00419159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00419159
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy
- NCT number
- NCT00419159
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 199 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Colorectal Cancer
- Interventions
- Everolimus (RAD001)
- First posted
- 2007-01-08
- Last updated
- 2019-04-23
- Results first posted
- 2011-05-16
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | Imaging every 8 weeks | RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response). |
| Primary | The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Imaging every 8 weeks | RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Best Over Response (BOR): Complete Response (CR, No lesions), Partial Response (PR, 30% decrease in lesions), and Stable Disease (SD, none of the above) |
| Secondary | Progression-free Survival (PFS) | Imaging every 8 weeks | Duration in months from the date of first study treatment to the date of the first documented disease progression or death due to any cause. |
| Secondary | Overall Survival (OS) | Every 3 months | Overall survival defined as the time from date of first study treatment to the date of death due to any cause. |
| Secondary | Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr). | From the first day of treatment until 28 days after discontinuation of study treatment | Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAEv3.0). On treatment death defined as deaths occurring no more than 28 days after the discontinuation of study treatment. |
| Secondary | Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 70 mg/Week | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. |
| Secondary | Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 10 mg/Day | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. |
| Secondary | Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS ) on Everolimus (RAD001) 70mg/Week | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. |
| Secondary | Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS) on Everolimus (RAD001) 10mg/Day | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. |
| Secondary | Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 70mg/Week | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | The efficacy variable that was compared in the biomarker analysis is DCR within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | Imaging every 8 weeks | Per Protocol Set | Percentage of participants | NUMBER |
| PRIMARY | The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Imaging every 8 weeks | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Imaging every 8 weeks | Progression- Free Survival (PFS) was analyzed in Full Analysis Set \[FAS\]. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Every 3 months | Overall Survival \[OS\] was analyzed in Full Analysis Set \[FAS\]. | Months | MEDIAN |
| SECONDARY | Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr). | From the first day of treatment until 28 days after discontinuation of study treatment | Safety set analysis | Participants | NUMBER |
| SECONDARY | Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 70 mg/Week | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | FAS | percentage of participants | NUMBER |
| SECONDARY | Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 10 mg/Day | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | FAS | percentage of participants | NUMBER |
| SECONDARY | Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS ) on Everolimus (RAD001) 70mg/Week | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | FAS | months | MEDIAN |
| SECONDARY | Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS) on Everolimus (RAD001) 10mg/Day | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | FAS | months | MEDIAN |
| SECONDARY | Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 70mg/Week | Screening and Day 1 of cycles 2, 3, 4 and end of treatment | FAS | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 70 mg/Week | Disease Control Rate (DCR) | 31.0 | 95% Confidence Interval 20.5 to 43.1 | Percentage of participants |
| Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 10 mg/Day | Disease Control Rate (DCR) | 32.4 | 95% Confidence Interval 21.8 to 44.5 | Percentage of participants |
| Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 70 mg/Week | Objective Response Rate (ORR) | 0 | 95% Confidence Interval 0 to 0 | Percentage of participants |
| Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 10 mg/Day | Objective Response Rate (ORR) | 0 | 95% Confidence Interval 0 to 0 | Percentage of participants |
| The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 70 mg/Week | Complete Response (CR) | 0 | Participants | |
| The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 10 mg/Day | Complete Response (CR) | 0 | Participants | |
| The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 70 mg/Week | Partial Response (PR) | 0 | Participants | |
| The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 10 mg/Day | Partial Response (PR) | 0 | Participants | |
| The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 70 mg/Week | Stable Disease (SD) | 25 | Participants | |
| The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Everolimus (RAD001) 10 mg/Day | Stable Disease (SD) | 26 | Participants |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus (RAD001) 70 mg/Week | 99 | |
| Overall Study | STARTED | Everolimus (RAD001) 10 mg/Day | 100 | |
| Overall Study | COMPLETED | Everolimus (RAD001) 70 mg/Week | 0 | |
| Overall Study | COMPLETED | Everolimus (RAD001) 10 mg/Day | 0 | |
| Overall Study | NOT COMPLETED | Everolimus (RAD001) 70 mg/Week | 99 | |
| Overall Study | NOT COMPLETED | Everolimus (RAD001) 10 mg/Day | 100 |
Source ClinicalTrials.gov
Adverse events248
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Everolimus (RAD001) 70 mg/Week | 25 | 99 | |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus (RAD001) 10 mg/Day | 19 | 100 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Everolimus (RAD001) 70 mg/Week | 9 | 99 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Everolimus (RAD001) 10 mg/Day | 4 | 100 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus (RAD001) 70 mg/Week | 2 | 99 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus (RAD001) 10 mg/Day | 5 | 100 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus (RAD001) 70 mg/Week | 16 | 99 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus (RAD001) 10 mg/Day | 18 | 100 | |
| other | Abdominal distension | Gastrointestinal disorders | Everolimus (RAD001) 70 mg/Week | 7 | 99 | |
| other | Abdominal distension | Gastrointestinal disorders | Everolimus (RAD001) 10 mg/Day | 5 | 100 |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus (RAD001) 70 mg/Week | ||
| Total, all-cause mortality | Everolimus (RAD001) 10 mg/Day | ||
| Total, other adverse events | Everolimus (RAD001) 70 mg/Week | 99 | 99 |
| Total, other adverse events | Everolimus (RAD001) 10 mg/Day | 98 | 100 |
| Total, serious adverse events | Everolimus (RAD001) 70 mg/Week | 34 | 99 |
| Total, serious adverse events | Everolimus (RAD001) 10 mg/Day | 22 | 100 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Everolimus (RAD001) 70 mg/Week vs Everolimus (RAD001) 10 mg/Day: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00419159
GET https://conductscience.org/api/trials/v1/NCT00419159/results?page=2