Trial · NCT04033991
Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
NCT04033991, Completed, Pfizer; results first posted 2022-02-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib. Trials, record NCT04033991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04033991
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
- NCT number
- NCT04033991
- Status
- Completed
- Enrollment
- 684 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Sunitinib, Axitinib
- First posted
- 2019-07-26
- Last updated
- 2023-04-06
- Results first posted
- 2022-02-18
- Limitations and caveats
Data was originally planned to be retrieved and analyzed from the database inception date (2002) until the end of June 2017. However, due to delay in data transfer, data retrieved and analysis was extended from end of June 2017 to end of June 2018. Required information for outcome measures- duration of response and durable response rate was not present in Christie NHS database. Hence, data could not be collected and analyzed for these outcome measures.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | PFS was duration measured from the first date of each treatment line to the date of disease progression (PD), end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from the date of progression or end of treatment date was assigned. PD per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. |
| Primary | Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | PFS: first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. MSKCC criteria had 5 risk factors: Karnofsky performance status (KPS) \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<lower limit of normal (LLN); lactate dehydrogenase 1.5\*upper limit of normal (ULN); corrected serum calcium \>10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors). PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was considered PD. |
| Primary | Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | PFS: duration measured from first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. IMDC criteria had 6 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; corrected serum calcium \>10 mg/dL; neutrophils and platelets \>LLN; hemoglobin \<LLN. Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors). PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered PD. |
| Secondary | Overall Survival (OS) | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. |
| Secondary | Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. MSKCC criteria had 5 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<LLN; lactate dehydrogenase 1.5\* ULN; corrected serum calcium \>10.0 mg/dL. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing = no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. |
| Secondary | Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. IMDC criteria had 6 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; corrected serum calcium \>10.0 mg/dL; neutrophils and platelets \>LLN and hemoglobin \<LLN. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors), unknown/missing =no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. |
| Secondary | Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1 | Start of treatment till BOR of CR, PR, PD, SD, Surgical CR, or death/initiation of new therapy, whichever occurred first; from 2002 to 30 June 2018, anytime in these 16 years (data retrieved and observed retrospectively for approximately 1.2 years) | BOR was recorded for CR, PR, SD, PD and surgical CR. RECIST v1.1, a) CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \<10mm; b) PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; c) PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5mm. Appearance of 1 or more new lesions; d) SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start; e) Surgical CR: disappearance of target, non-target lesions, normalization of tumor markers, pathological lymph nodes had short axis measuring \<10mm as result of surgery. Alive participants with no events were censored at final study cutoff date. |
| Secondary | Objective Response Rate (ORR) | From start of treatment until CR,PR,PD,death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16 years (from data retrieved and observed retrospectively for approximately 1.2 years) | ORR was defined as the percentage of participants who achieved a BOR of CR or PR as per RECIST v1.1. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to 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 was considered progression. Alive participants who did not have event were censored at final study cutoff date. |
| Secondary | Duration of Response (DOR) | From date of first documented CR/PR until PD/death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16years (data retrieved and observed retrospectively for approximately 1.2 years) | DOR was defined as the time between the date of the first documented confirmed response (PR or CR) and the date of the first documented progression or death due to any cause. Alive participants who did not have event were censored at final study cutoff date. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \<10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. PD was defined as at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. |
| Secondary | Time to Treatment Discontinuation (TTD) | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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) | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Months | MEDIAN |
| PRIMARY | Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here Number Analyzed signifies number of participants evaluable for specified rows. | Months | MEDIAN |
| PRIMARY | Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here Number Analyzed signifies number of participants evaluable for specified rows. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, Number Analyzed signifies number of participants evaluable for specified rows. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, Number Analyzed signifies number of participants evaluable for specified rows. | Months | MEDIAN |
| SECONDARY | Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1 | Start of treatment till BOR of CR, PR, PD, SD, Surgical CR, or death/initiation of new therapy, whichever occurred first; from 2002 to 30 June 2018, anytime in these 16 years (data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | From start of treatment until CR,PR,PD,death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16 years (from data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From date of first documented CR/PR until PD/death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16years (data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Required information for this outcome measure was not present in Christie NHS database. Hence, data could not be collected and analyzed for this outcome measure. | ||
| SECONDARY | Time to Treatment Discontinuation (TTD) | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Months | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group98
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) | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | 8.394 | 95% Confidence Interval 7.556 to 9.889 | Months | |
| Progression Free Survival (PFS) | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | 6.177 | 95% Confidence Interval 4.928 to 9.331 | Months | |
| Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | Favorable | 14.784 | 95% Confidence Interval 11.729 to 20.008 | Months |
| Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | Favorable | 12.649 | 95% Confidence Interval 4.895 to 15.639 | Months |
| Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | Intermediate | 8.986 | 95% Confidence Interval 7.589 to 10.021 | Months |
| Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | Intermediate | 8.903 | 95% Confidence Interval 5.290 to 11.762 | Months |
| Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | Poor | 2.628 | 95% Confidence Interval 1.774 to 4.600 | Months |
| Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | Poor | 1.610 | 95% Confidence Interval 0.460 to 2.661 | Months |
| Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | Unknown/missing (no information available) | NA | 95% Confidence Interval NA to NA | Months |
| Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | Unknown/missing (no information available) | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With mRCC and/or aRCC | 684 | |
| Overall Study | Participants Who Took First-line Sunitinib Therapy | Participants With mRCC and/or aRCC | 622 | |
| Overall Study | Participants Who Took Second-line Axitinib Therapy | Participants With mRCC and/or aRCC | 121 | |
| Overall Study | Participants Who Took First-line Sunitinib Therapy and Then Second-line Axitinib Therapy | Participants With mRCC and/or aRCC | 59 | |
| Overall Study | Participants Who Took Drugs Other Than Sunitinib as First-line and Then Second-line Axitinib Therapy | Participants With mRCC and/or aRCC | 62 | |
| Overall Study | COMPLETED | Participants With mRCC and/or aRCC | 684 | |
| Overall Study | NOT COMPLETED | Participants With mRCC and/or aRCC | 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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | 0 | 0 |
| Total, all-cause mortality | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | 0 | 0 |
| Total, other adverse events | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | 0 | 0 |
| Total, other adverse events | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | 0 | 0 |
| Total, serious adverse events | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | 0 | 0 |
| Total, serious adverse events | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39382446 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment vs Participants With mRCC and/or aRCC: Second Line Axitinib Treatment: Number of Participants Who Started Systemic Therapy Within 1 Year of Diagnosis | Trial comparisons |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment vs Participants With mRCC and/or aRCC: Second Line Axitinib Treatment: Number of Participants With Karnofsky Performance Status (KPS) Less Than 80 Percent (%) | Trial comparisons |
Participants With mRCC and/or aRCC: First Line Sunitinib Treatment vs Participants With mRCC and/or aRCC: Second Line Axitinib Treatment: Number of Participants With Hemoglobin Less Than Lower Limit of Normal (LLN) | 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.
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