Trial · NCT00879333
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
NCT00879333, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-04-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC). Trials, record NCT00879333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00879333
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
- NCT number
- NCT00879333
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 656 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Advanced Gastric Cancer
- Interventions
- Everolimus, Everolimus placebo, Best Supportive Care (BSC)
- First posted
- 2009-04-10
- Last updated
- 2015-11-03
- Other registries' IDs
- eudract:2008-006544-20
- Results first posted
- 2015-04-06
- Limitations and caveats
- 4 randomized patients, 2 patients each from the everolimus and placebo arms were excluded from the safety analyses as they did not receive any dose of study treatment.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 2.5 years | The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method. |
| Secondary | Progression Free Survival (PFS) | 2.5 years | Progression free survival was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, where progression was based on Investigator assessment of baseline and post-baseline scans according to RECIST. Progression free survival was censored if no PFS event was observed before the first to occur out of (i) the cut-off date, or (ii) the date when a further anticancer therapy was started. The censoring date was the date of the last adequate tumor assessment before either of these two events occurred. If a PFS event was observed after two or more missing or non-evaluable tumor assessments, then the date of progression was censored at the date of the last adequate tumor assessment; for a PFS event observed after a single missing or non-evaluable tumor assessment, the actual date of disease progression was used. Anslsis was done using Kaplan-Meier estimates method. |
| Secondary | Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores | 2.5 years | The EORTC QLQ-C30 global health status/quality of life sub-scale (QL) was pre-specified as the primary domain of interest, followed by physical functioning (PF), social functioning (SF) and emotional functioning (EF).The EORTC QLQ-C30 questionnaire, along with a module specific for gastric cancer patients (EORTC QLQ-STO22), was used to evaluate PRO. The QLQ-C30 has five function scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and a global health status/quality of life scale. In addition, there are questions that assess specific symptoms. The QLQ-STO22 consists of 22 questions that make up five multi-item scales (dysphagia, pain, reflux, eating and anxiety) and four single-item scales (dry mouth, tasting, body image and hair loss). |
| Secondary | Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score | 2.5 years | The ECOG PS scale was used to classify patients according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). An analysis of the time to definitive deterioration of the ECOG PS by one category of the score from baseline was performed. Definitive deterioration was defined as a definitive increase by one category from baseline in ECOG PS, with no later improvements observed during the course of the study. A single measure reporting an increase in ECOG PS is sufficient to consider it as a definitive worsening only if it was the last one available for the patient. Kaplan-Meier method was used to estimate the distribution function of time to definitive worsening. |
| Secondary | Overall Response Rate (ORR) | 2.5 years | ORR was defined as the proportion of patients with measurable disease in whom best overall response (OR) was either complete response (CR) or partial response (PR) according to RECIST criteria. |
| Secondary | Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5 | Week 5 | Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose. |
| Secondary | Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5 | Week 5 | Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | 2.5 years | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | 2.5 years | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization. | Months | MEDIAN |
| SECONDARY | Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores | 2.5 years | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization. | Months | MEDIAN |
| SECONDARY | Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score | 2.5 years | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | 2.5 years | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization. | Participants | NUMBER |
| SECONDARY | Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5 | Week 5 | PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) \& Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily. | ng/mL | MEAN |
| SECONDARY | Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5 | Week 5 | PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) \& Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily. | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Everolimus 10mg/Daily | 5.39 | 95% Confidence Interval 4.80 to 6.01 | Months | |
| Overall Survival (OS) | Placebo | 4.34 | 95% Confidence Interval 3.81 to 5.49 | Months | |
| Progression Free Survival (PFS) | Everolimus 10mg/Daily | 1.68 | 95% Confidence Interval 1.51 to 1.94 | Months | |
| Progression Free Survival (PFS) | Placebo | 1.41 | 95% Confidence Interval 1.38 to 1.45 | Months | |
| Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores | Everolimus 10mg/Daily | In QL score by at least 5 % compared to baseline | 1.51 | 95% Confidence Interval 1.28 to 1.84 | Months |
| Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores | Placebo | In QL score by at least 5 % compared to baseline | 1.45 | 95% Confidence Interval 1.05 to 1.68 | Months |
| Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores | Everolimus 10mg/Daily | In PF score by at least 5 % compared to baseline | 1.35 | 95% Confidence Interval 1.12 to 1.54 | Months |
| Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores | Placebo | In PF score by at least 5 % compared to baseline | 1.15 | 95% Confidence Interval 1.02 to 1.64 | Months |
| Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores | Everolimus 10mg/Daily | In SF score by at least 5 % compared to baseline | 1.87 | 95% Confidence Interval 1.84 to 2.30 | Months |
| Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores | Placebo | In SF score by at least 5 % compared to baseline | 1.87 | 95% Confidence Interval 1.64 to 2.46 | Months |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus 10mg/Daily | 439 | |
| Overall Study | STARTED | Placebo | 217 | |
| Overall Study | Discontinued Study Treatment | Everolimus 10mg/Daily | 428 | |
| Overall Study | Discontinued Study Treatment | Placebo | 217 | |
| Overall Study | COMPLETED | Everolimus 10mg/Daily | 11 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Everolimus 10mg/Daily | 428 | |
| Overall Study | NOT COMPLETED | Placebo | 217 |
Source ClinicalTrials.gov
Adverse events494
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 10mg / Daily | 108 | 437 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 42 | 215 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus 10mg / Daily | 30 | 437 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 3 | 215 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus 10mg / Daily | 47 | 437 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 6 | 215 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus 10mg / Daily | 77 | 437 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 4 | 215 | |
| other | Abdominal distension | Gastrointestinal disorders | Everolimus 10mg / Daily | 39 | 437 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 20 | 215 |
1 to 10 of 494Source ClinicalTrials.gov
See all 494 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus 10mg / Daily | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Everolimus 10mg / Daily | 416 | 437 |
| Total, other adverse events | Placebo | 193 | 215 |
| Total, serious adverse events | Everolimus 10mg / Daily | 210 | 437 |
| Total, serious adverse events | Placebo | 89 | 215 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24043745 | DERIVED |
Source PubMed
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 10mg / Daily vs Placebo: 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/NCT00879333
GET https://conductscience.org/api/trials/v1/NCT00879333/results?page=2