Trial · NCT01108445
Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma
NCT01108445, Phase 2, Completed, Duke University; results first posted 2016-06-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma. Trials, record NCT01108445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01108445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma
- NCT number
- NCT01108445
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Advanced Non-clear Cell Renal Cell Carcinoma
- Interventions
- Everolimus, Sunitinib
- First posted
- 2010-04-22
- Last updated
- 2018-01-16
- Results first posted
- 2016-06-20
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anti-tumor Activity as Measured by Median Progression Free Survival Time | 24 Months | The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Progression Free Survival Rates | 6, 12 and 24 months | 6-, 12-, and 24-month rates of PFS in each arm will be compared for each treatment arm. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | PFS Expressed in Months | 24 months | Progression-free survival (PFS) expressed in months as compared to an historic control (interferon-treated clear cell RCC control arm from the sunitinib phase III study). Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Overall Response Rate | 24 months | Defined as complete response \[CR\] and partial response \[PR\] by RECIST 1.1 criteria in each treatment arm.Overall Response Rate (ORR) = CR + PR. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Percentage of Participants With Stable Disease (SD) | Baseline to 36 months | Percentage of participants with stable disease during treatment is defined as stable disease \[SD\] by RECIST 1.1 criteria as calculated in each treatment arm. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | 12 Week Clinical Benefit Rate as Percentage | Baseline to 36 months | Rate of complete or partial response or stable disease by the RECIST 1.1 criteria lasting ≥ 12 weeks prior to progression. Benefit rate is defined as complete response \[CR\] and partial response \[PR\] and stable disease \[SD\] by RECIST 1.1 criteria in each treatment arm. Benefit rate = CR + PR + SD. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Overall Survival Rates | 6, 12, 24, 36 months | To compare overall survival (OS) rates at 6, 12, 24, and 36 months and over time in each treatment arm. |
| Secondary | Best Tumor Shrinkage as a Percentile in Each Arm | 24 months | To compare the best tumor shrinkage as a percentile in each treatment arm. The percentile change at each follow up visit is calculated by measuring the percentage change in the Sum of lesion measurement from baseline. The best tumor shrinkage is lowest percentile change. A decrease is indicated by a negative percentage. |
| Secondary | Median Duration of Response (CR, PR, and SD) | 24 months | To compare the median duration of response (CR, PR, and SD) in each treatment arm. According to RECIST 1.1, Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Median OS | Up to 40 months | To compare the median OS in each treatment arm. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Anti-tumor Activity as Measured by Median Progression Free Survival Time | 24 Months | Months | MEDIAN | |
| SECONDARY | Progression Free Survival Rates | 6, 12 and 24 months | percentage of participants | NUMBER | |
| SECONDARY | PFS Expressed in Months | 24 months | Months | MEDIAN | |
| SECONDARY | Overall Response Rate | 24 months | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Stable Disease (SD) | Baseline to 36 months | percentage of participants | NUMBER | |
| SECONDARY | 12 Week Clinical Benefit Rate as Percentage | Baseline to 36 months | percentage of particpants | NUMBER | |
| SECONDARY | Overall Survival Rates | 6, 12, 24, 36 months | percentage probability | NUMBER | |
| SECONDARY | Best Tumor Shrinkage as a Percentile in Each Arm | 24 months | percentile decrease | MEDIAN | |
| SECONDARY | Median Duration of Response (CR, PR, and SD) | 24 months | months | MEDIAN | |
| SECONDARY | Median OS | Up to 40 months | months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Anti-tumor Activity as Measured by Median Progression Free Survival Time | RAD001 | 5.6 | 80% Confidence Interval 5.5 to 6.0 | Months | |
| Anti-tumor Activity as Measured by Median Progression Free Survival Time | Sunitinib | 8.3 | 80% Confidence Interval 5.8 to 11.4 | Months | |
| Progression Free Survival Rates | RAD001 | 6 Months | 40.3 | 95% Confidence Interval 27.3 to 52.8 | percentage of participants |
| Progression Free Survival Rates | Sunitinib | 6 Months | 55.0 | 95% Confidence Interval 40.1 to 67.7 | percentage of participants |
| Progression Free Survival Rates | RAD001 | 12 Months | 17.0 | 95% Confidence Interval 8.4 to 28.3 | percentage of participants |
| Progression Free Survival Rates | Sunitinib | 12 Months | 37.7 | 95% Confidence Interval 24.1 to 51.2 | percentage of participants |
| Progression Free Survival Rates | RAD001 | 24 Months | 9.3 | 95% Confidence Interval 3.0 to 20.2 | percentage of participants |
| Progression Free Survival Rates | Sunitinib | 24 Months | 22.8 | 95% Confidence Interval 11.7 to 36.1 | percentage of participants |
| PFS Expressed in Months | RAD001 | 5.6 | 95% Confidence Interval 4.4 to 6.1 | Months | |
| PFS Expressed in Months | Sunitinib | 8.3 | 95% Confidence Interval 5.6 to 13.0 | Months |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RAD001 | 57 | |
| Overall Study | STARTED | Sunitinib | 51 | |
| Overall Study | COMPLETED | RAD001 | 1 | |
| Overall Study | COMPLETED | Sunitinib | 2 | |
| Overall Study | NOT COMPLETED | RAD001 | 56 | |
| Overall Study | NOT COMPLETED | Sunitinib | 49 |
Source ClinicalTrials.gov
Adverse events826
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 | RAD001 | 16 | 57 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib | 14 | 51 | |
| other | Leukopenia | Blood and lymphatic system disorders | RAD001 | 2 | 57 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib | 4 | 51 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | RAD001 | 1 | 57 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Sunitinib | 0 | 51 | |
| other | Lymphopenia | Blood and lymphatic system disorders | RAD001 | 1 | 57 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Sunitinib | 0 | 51 | |
| other | Neutropenia | Blood and lymphatic system disorders | RAD001 | 1 | 57 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib | 5 | 51 |
1 to 10 of 826Source ClinicalTrials.gov
See all 826 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RAD001 | ||
| Total, all-cause mortality | Sunitinib | ||
| Total, other adverse events | RAD001 | 57 | 57 |
| Total, other adverse events | Sunitinib | 51 | 51 |
| Total, serious adverse events | RAD001 | 36 | 57 |
| Total, serious adverse events | Sunitinib | 41 | 51 |
Source ClinicalTrials.gov
Papers3
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 |
|---|
| RAD001 vs Sunitinib: 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/NCT01108445
GET https://conductscience.org/api/trials/v1/NCT01108445/results?page=2