Trial · NCT01545817
Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma
NCT01545817, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2019-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma. Trials, record NCT01545817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01545817
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma
- NCT number
- NCT01545817
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Pazopanib followed by everolimus
- First posted
- 2012-03-07
- Last updated
- 2019-10-09
- Results first posted
- 2019-10-09
- Limitations and caveats
the trial terminated early because the information gained from this study was sufficient to meet the objectives for which the study had been set up and would be no longer clinically relevant for the second-line management of RCC patients.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST | Throughout the study period, up to 4 years | Time between the date of first everolimus dose and date of disease progression or death (whichever comes first) in patients treated initially with pazopanib. Disease progression is measured by RECIST (Response Evaluation Criteria in Solid Tumors), which is at least a 20% increase in the sum of the target lesion longest diameters (LDs). |
| Secondary | Progression Free Survival (PFS) Rates | 3 months, 6 months | PFS rates 3 and 6 months after date of first dose of second-line everolimus treatment. |
| Secondary | Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST | Throughout the study, up to 4 years | Percentage of patients with Complete or Partial Response at any time following the start of second-line everolimus treatment as per RECIST. RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs. |
| Secondary | Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST | Throughout the study period, up to 4 years | Percentage of patients with Complete or Partial Response at any time following the start of first-line pazopanib treatment. RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs. |
| Secondary | Overall Survival of Everolimus (OSE) | Throughout the study period, up to 4 years | Time from first everolimus dose until death due to any cause |
| Secondary | Overall Survival From the Start (OSS) of Study Treatment | Throughout the study, up to 4 years | Time from first pazopanib dose until death due to any cause in patients who received at least one dose of pazopanib followed by everolimus |
| Secondary | PFS for the Pazopanib Treatment Period Using RECIST | Throughout the study period, up to 4 years | Time from first pazopanib dose until disease progression or death from any cause (whichever occurred earlier), provided this occurred prior to the start of everolimus and within 6 months of last dose of pazopanib |
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 | Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST | Throughout the study period, up to 4 years | Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Rates | 3 months, 6 months | Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus. | Survival probability | NUMBER |
| SECONDARY | Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST | Throughout the study, up to 4 years | Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus. | Percentages of Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST | Throughout the study period, up to 4 years | Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus. | Percentages of participants | NUMBER |
| SECONDARY | Overall Survival of Everolimus (OSE) | Throughout the study period, up to 4 years | ITT | months | MEDIAN |
| SECONDARY | Overall Survival From the Start (OSS) of Study Treatment | Throughout the study, up to 4 years | ATS | Months | MEDIAN |
| SECONDARY | PFS for the Pazopanib Treatment Period Using RECIST | Throughout the study period, up to 4 years | ATS | Months | NUMBER |
Source ClinicalTrials.gov
Results by group10
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) for the Everolimus Treatment Period Using RECIST | Everolimus | 5.1 | 95% Confidence Interval 3.4 to 6.8 | months | |
| Progression Free Survival (PFS) Rates | All Patients | 3 months | 0.737 | 95% Confidence Interval 0.554 to 0.854 | Survival probability |
| Progression Free Survival (PFS) Rates | All Patients | 6 months | 0.355 | 95% Confidence Interval 0.196 to 0.517 | Survival probability |
| Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST | All Patients | Complete response | 0.0 | 95% Confidence Interval 0.00 to 9.3 | Percentages of Participants |
| Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST | All Patients | Partial response | 7.9 | 95% Confidence Interval 1.7 to 21.4 | Percentages of Participants |
| Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST | All Patients | Complete response | 6.8 | 95% Confidence Interval 2.2 to 15.1 | Percentages of participants |
| Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST | All Patients | Partial response | 39.2 | 95% Confidence Interval 28.0 to 51.2 | Percentages of participants |
| Overall Survival of Everolimus (OSE) | Everolimus | 15.6 | 95% Confidence Interval 9.9 to 25.3 | months | |
| Overall Survival From the Start (OSS) of Study Treatment | Pazopanib | 35.7 | 95% Confidence Interval 26.7 to NA | Months | |
| PFS for the Pazopanib Treatment Period Using RECIST | Pazopanib | 11.0 | 95% Confidence Interval 7.2 to 14.8 | Months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pazopanib | STARTED | Pazopanib | 74 | |
| Pazopanib | STARTED | Everolimus | 0 | |
| Pazopanib | COMPLETED | Pazopanib | 0 | |
| Pazopanib | COMPLETED | Everolimus | 0 | |
| Pazopanib | NOT COMPLETED | Pazopanib | 74 | |
| Pazopanib | NOT COMPLETED | Everolimus | 0 | |
| Everolimus | STARTED | Pazopanib | 0 | |
| Everolimus | STARTED | Everolimus | 38 | |
| Everolimus | COMPLETED | Pazopanib | 0 | |
| Everolimus | COMPLETED | Everolimus | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events316
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 | Pazopanib | 3 | 74 | |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus | 9 | 38 | |
| other | Palpitations | Cardiac disorders | Pazopanib | 4 | 74 | |
| other | Palpitations | Cardiac disorders | Everolimus | 1 | 38 | |
| other | Hypothyroidism | Endocrine disorders | Pazopanib | 8 | 74 | |
| other | Hypothyroidism | Endocrine disorders | Everolimus | 0 | 38 | |
| other | Abdominal Pain | Gastrointestinal disorders | Pazopanib | 15 | 74 | |
| other | Abdominal Pain | Gastrointestinal disorders | Everolimus | 1 | 38 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Pazopanib | 4 | 74 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Everolimus | 2 | 38 |
1 to 10 of 316Source ClinicalTrials.gov
See all 316 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib | 5 | 74 |
| Total, all-cause mortality | Everolimus | 3 | 38 |
| Total, other adverse events | Pazopanib | 73 | 74 |
| Total, other adverse events | Everolimus | 34 | 38 |
| Total, serious adverse events | Pazopanib | 47 | 74 |
| Total, serious adverse events | Everolimus | 16 | 38 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pazopanib vs Everolimus: deaths from any cause | Trial comparisons |
| Pazopanib vs Everolimus: serious adverse events | 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/NCT01545817
GET https://conductscience.org/api/trials/v1/NCT01545817/events?page=2