Trial · NCT04076787
Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
NCT04076787, Completed, Pfizer; results first posted 2019-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib. Trials, record NCT04076787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04076787
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
- NCT number
- NCT04076787
- Status
- Completed
- Enrollment
- 1,769 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Metastatic Renal Cell Carcinoma
- Interventions
- Sunitinib
- First posted
- 2019-09-03
- Last updated
- 2023-04-06
- Results first posted
- 2019-10-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 60 months | Overall survival was defined as the time between index date and death due to any cause or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy. |
| Primary | Time to First-Line Sunitinib Treatment Discontinuation | 60 months | Time to treatment discontinuation was defined as the time between index date and either discontinuation of first-line sunitinib therapy due to any reason including disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy. |
| Primary | Number of Participants Who Discontinued First-Line Sunitinib Treatment | 60 months | In this outcome measure, participants who discontinued treatment due to any reason like disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability are reported. |
| Primary | Percentage of Participants With Objective Response (OR) | 60 months | Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters. |
| Primary | Percentage of Participants With Progressive Disease | 60 months | Progressive disease (PD) was defined as an increase in visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. |
| Primary | Percentage of Participants With Stable Disease | 60 months | Stable disease was defined as no change in size of visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), stable disease neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | 60 months | Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | months | MEDIAN |
| PRIMARY | Time to First-Line Sunitinib Treatment Discontinuation | 60 months | Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | months | MEDIAN |
| PRIMARY | Number of Participants Who Discontinued First-Line Sunitinib Treatment | 60 months | Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Objective Response (OR) | 60 months | Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Progressive Disease | 60 months | Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Stable Disease | 60 months | Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | IMDC Prognostic Risk Group: Favorable | 52.1 | 95% Confidence Interval 43.4 to 61.2 | months | |
| Overall Survival | IMDC Prognostic Risk Group: Intermediate | 31.5 | 95% Confidence Interval 28.9 to 33.9 | months | |
| Overall Survival | IMDC Prognostic Risk Group: Poor | 9.8 | 95% Confidence Interval 8.3 to 11.4 | months | |
| Time to First-Line Sunitinib Treatment Discontinuation | IMDC Prognostic Risk Group: Favorable | 15.0 | 95% Confidence Interval 12.4 to 17.3 | months | |
| Time to First-Line Sunitinib Treatment Discontinuation | IMDC Prognostic Risk Group: Intermediate | 8.5 | 95% Confidence Interval 8.0 to 9.5 | months | |
| Time to First-Line Sunitinib Treatment Discontinuation | IMDC Prognostic Risk Group: Poor | 4.2 | 95% Confidence Interval 3.4 to 4.9 | months | |
| Number of Participants Who Discontinued First-Line Sunitinib Treatment | IMDC Prognostic Risk Group: Favorable | Disease progression | 91 | Participants | |
| Number of Participants Who Discontinued First-Line Sunitinib Treatment | IMDC Prognostic Risk Group: Intermediate | Disease progression | 316 | Participants | |
| Number of Participants Who Discontinued First-Line Sunitinib Treatment | IMDC Prognostic Risk Group: Poor | Disease progression | 122 | Participants | |
| Number of Participants Who Discontinued First-Line Sunitinib Treatment | IMDC Prognostic Risk Group: Favorable | Toxicity | 52 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMDC Prognostic Risk Group: Favorable | 318 | |
| Overall Study | STARTED | IMDC Prognostic Risk Group: Intermediate | 1,031 | |
| Overall Study | STARTED | IMDC Prognostic Risk Group: Poor | 420 | |
| Overall Study | COMPLETED | IMDC Prognostic Risk Group: Favorable | 318 | |
| Overall Study | COMPLETED | IMDC Prognostic Risk Group: Intermediate | 1,031 | |
| Overall Study | COMPLETED | IMDC Prognostic Risk Group: Poor | 420 | |
| Overall Study | NOT COMPLETED | IMDC Prognostic Risk Group: Favorable | 0 | |
| Overall Study | NOT COMPLETED | IMDC Prognostic Risk Group: Intermediate | 0 | |
| Overall Study | NOT COMPLETED | IMDC Prognostic Risk Group: Poor | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMDC Prognostic Risk Group: Favorable | 0 | 0 |
| Total, all-cause mortality | IMDC Prognostic Risk Group: Intermediate | 0 | 0 |
| Total, all-cause mortality | IMDC Prognostic Risk Group: Poor | 0 | 0 |
| Total, other adverse events | IMDC Prognostic Risk Group: Favorable | 0 | 0 |
| Total, other adverse events | IMDC Prognostic Risk Group: Intermediate | 0 | 0 |
| Total, other adverse events | IMDC Prognostic Risk Group: Poor | 0 | 0 |
| Total, serious adverse events | IMDC Prognostic Risk Group: Favorable | 0 | 0 |
| Total, serious adverse events | IMDC Prognostic Risk Group: Intermediate | 0 | 0 |
| Total, serious adverse events | IMDC Prognostic Risk Group: Poor | 0 | 0 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04076787
GET https://conductscience.org/api/trials/v1/NCT04076787/results?page=2