N/A
N=684
Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
Carcinoma · Renal Cell
Bottom Line
View on ClinicalTrials.gov: NCT04033991 ↗Enrolled (actual)
684
Serious AEs
—
Results posted
Feb 2022
Primary outcome: Primary: Progression Free Survival (PFS) — 8.394; 6.177 Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sunitinib (Drug); Axitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
8.394; 6.177 | — |
| PRIMARY Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification |
14.784; 12.649; 8.986; 8.903; 2.628; 1.610 | <0.0001 sig |
| PRIMARY Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification |
13.979; 12.649; 9.955; 7.162; 5.569; 2.990 | <0.0001 sig |
| SECONDARY Overall Survival (OS) |
18.333; 15.836 | — |
| SECONDARY Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification |
40.246; NA; 18.497; 16.164; 5.322; 2.694 | <0.0001 sig |
| SECONDARY Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification |
34.103; NA; 20.435; 16.394; 9.347; 8.049 | <0.0001 sig |
| 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 |
19; 0; 127; 17; 252; 50 | — |
| SECONDARY Objective Response Rate (ORR) |
23.5; 14.0 | — |
| SECONDARY Duration of Response (DOR) |
— | — |
| SECONDARY Time to Treatment Discontinuation (TTD) |
8.509; 6.899 | — |
| SECONDARY Time to Treatment Discontinuation (TTD): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification |
15.836; 12.649; 9.051; 8.903; 2.760; 1.610 | <0.0001 sig |
| SECONDARY Time to Treatment Discontinuation (TTD): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification |
15.129; 12.649; 9.988; 7.359; 5.651; 3.680 | <0.0001 sig |
| SECONDARY Durable Response Rate (DRR) |
— | — |
Summary
Research Questions:
To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC).
Primary Objective:
1. What is the progression free survival (PFS) of patients treated in first line with sunitinib, and stratified by Memorial Sloan-Kettering Cancer Center / International Metastatic Renal Cell Carcinoma Database Consortium (MSKCC/IMDC) risk category (favourable, intermediate, poor)?
2. What is the progression free survival (PFS) of patients treated in second line with axitinib, and stratified by MSKCC/IMDC risk category (favourable, intermediate, poor)?
Eligibility Criteria
Inclusion criteria
- Over the age of 18 years
- Diagnosis of renal cell carcinoma
- Treatment with sunitinib and/or axitinib
- Timeframe: from database inception date (2002) until June 30, 2018.
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study:
- Under the age of 18 years
- Diagnosis other than renal cell carcinoma
- No treatment with sunitinib and/or axitinib
Data sourced from ClinicalTrials.gov (NCT04033991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.