Trial · NCT00719264
Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
NCT00719264, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2014-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer. Trials, record NCT00719264. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00719264
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
- NCT number
- NCT00719264
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 365 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Carcinoma, Adenocarcinoma, Renal Cell, Nephroid Carcinoma, Hypernephroid
- Interventions
- RAD001(everolimus), interferon alfa-2a, bevacizumab
- First posted
- 2008-07-21
- Last updated
- 2017-03-20
- Other registries' IDs
- eudract:2008-000077-38
- Results first posted
- 2014-05-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date. | Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall. |
| Secondary | Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012) | Overall survival (OS) was defined as the time of randomization to the date of death due to any cause. |
| Secondary | Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Time from first participant randomized until 31Dec2011, cutoff date. | Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall. |
| Secondary | Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date. | The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment. |
| Secondary | Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths | From the first participant randomized until the last patient discontinued the study treatment + 28 days | Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle. |
| Secondary | Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units | Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011 | The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is 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 participant. |
| Secondary | Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10% | Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011 | 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). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. 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 participant. |
| Secondary | Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab | From the date of the first participant treated until the last patient discontinued the study treatment + 28 days | This outcome measure was assessed continuously. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date. | Full Analysis Set: This set consists of all randomized participants. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012) | Full Analysis Set: This set consists of all randomized participants. | Months | MEDIAN |
| SECONDARY | Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Time from first participant randomized until 31Dec2011, cutoff date. | Full Analysis Set: This set consists of all randomized participants. | Number of participants | NUMBER |
| SECONDARY | Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date. | A subset of participants from the full analysis set were analyzed. The full analysis set consists of all randomized participants. the subset includes participants who were complete responders or partial responders. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths | From the first participant randomized until the last patient discontinued the study treatment + 28 days | Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment. | Participants | NUMBER |
| SECONDARY | Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units | Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011 | Full Analysis Set: This set consists of all randomized participants. | Months | MEDIAN |
| SECONDARY | Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10% | Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011 | Full Analysis Set: This set consists of all randomized participants. | Months | MEDIAN |
| SECONDARY | Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab | From the date of the first participant treated until the last patient discontinued the study treatment + 28 days | Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, RAD001 (Everolimus) | 9.3 | 95% Confidence Interval 8.1 to 11.2 | Months | |
| Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, Interferon Alfa-2a (IFN) | 10.0 | 95% Confidence Interval 8.3 to 12.9 | Months | |
| Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, RAD001 (Everolimus) | 27.1 | 95% Confidence Interval 19.9 to 35.3 | Months | |
| Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, Interferon Alfa-2a (IFN) | 27.1 | 95% Confidence Interval 20.4 to 30.8 | Months | |
| Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, RAD001 (Everolimus) | Complete response (CR) | 0 | Number of participants | |
| Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, Interferon Alfa-2a (IFN) | Complete response (CR) | 1 | Number of participants | |
| Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, RAD001 (Everolimus) | Partial response (PR) | 49 | Number of participants | |
| Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, Interferon Alfa-2a (IFN) | Partial response (PR) | 50 | Number of participants | |
| Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, RAD001 (Everolimus) | Stable disease (SD) | 90 | Number of participants | |
| Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Bevacizumab, Interferon Alfa-2a (IFN) | Stable disease (SD) | 84 | Number of participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab, RAD001 (Everolimus) | 182 | |
| Overall Study | STARTED | Bevacizumab, Interferon Alfa-2a (IFN) | 183 | |
| Overall Study | Full Analysis Set | Bevacizumab, RAD001 (Everolimus) | 182 | |
| Overall Study | Full Analysis Set | Bevacizumab, Interferon Alfa-2a (IFN) | 183 | |
| Overall Study | Safety Set | Bevacizumab, RAD001 (Everolimus) | 180 | |
| Overall Study | Safety Set | Bevacizumab, Interferon Alfa-2a (IFN) | 181 | |
| Overall Study | COMPLETED | Bevacizumab, RAD001 (Everolimus) | 0 | |
| Overall Study | COMPLETED | Bevacizumab, Interferon Alfa-2a (IFN) | 0 | |
| Overall Study | NOT COMPLETED | Bevacizumab, RAD001 (Everolimus) | 182 | |
| Overall Study | NOT COMPLETED | Bevacizumab, Interferon Alfa-2a (IFN) | 183 |
Source ClinicalTrials.gov
Adverse events508
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 | Bevacizumab, RAD001 (Everolimus) | 35 | 180 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Bevacizumab, Interferon Alfa-2a (IFN) | 35 | 181 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Bevacizumab, RAD001 (Everolimus) | 4 | 180 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Bevacizumab, Interferon Alfa-2a (IFN) | 12 | 181 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Bevacizumab, RAD001 (Everolimus) | 4 | 180 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Bevacizumab, Interferon Alfa-2a (IFN) | 11 | 181 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Bevacizumab, RAD001 (Everolimus) | 7 | 180 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Bevacizumab, Interferon Alfa-2a (IFN) | 21 | 181 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Bevacizumab, RAD001 (Everolimus) | 16 | 180 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Bevacizumab, Interferon Alfa-2a (IFN) | 29 | 181 |
1 to 10 of 508Source ClinicalTrials.gov
See all 508 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab, RAD001 (Everolimus) | ||
| Total, all-cause mortality | Bevacizumab, Interferon Alfa-2a (IFN) | ||
| Total, other adverse events | Bevacizumab, RAD001 (Everolimus) | 173 | 180 |
| Total, other adverse events | Bevacizumab, Interferon Alfa-2a (IFN) | 179 | 181 |
| Total, serious adverse events | Bevacizumab, RAD001 (Everolimus) | 79 | 180 |
| Total, serious adverse events | Bevacizumab, Interferon Alfa-2a (IFN) | 76 | 181 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Bevacizumab, RAD001 (Everolimus) vs Bevacizumab, Interferon Alfa-2a (IFN): 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/NCT00719264
GET https://conductscience.org/api/trials/v1/NCT00719264/results?page=2