Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.

Pfizer

Status: Completed

Conditions: Carcinoma; Renal Cell

Treatments: Drug: Axitinib; Drug: Sunitinib

Study type: Observational

Funder types: Industry

Identifiers

NCT04033991

X9001180

Details and patient eligibility

About

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)?

Full description

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)?

Secondary Objectives:

First Line:

1. What is the overall survival (OS) of all patients in first line with sunitinib, and stratified by MSKCC risk (favourable, intermediate, poor)?

2. What is the duration of therapy with sunitinib in first line (using time to treatment discontinuation [TTD]) for all patients and stratified by MSKCC risk (favourable, intermediate, poor)

3. Objective response rate (ORR)

4. Duration of objective response (complete response [CR] or partial response [PR])

5. Examine factors that predict TTD, e.g. risk stratification, or individual/grouped parameters that comprise the prognostic classification systems

   1. Less than one year from time of diagnosis
   2. Karnovsky performance status less than 80%
   3. Haemoglobin less than the lower limit of normal (e.g. less than 12 g/dl)
   4. Serum calcium great than the upper limit of normal (e.g. 10 mg/dl or : 2.5 mmol/l)
   5. Neutrophil greater than the upper limit of normal (e.g. greater than 7.0 x109 dl)
   6. Platelets greater than the upper limit of normal (e.g. greater than 400 000)
   7. Lactate dehydrogenase greater than 1.5 times the upper limit of normal
   8. Fuhrmann grade of tumour
   9. Tumour subtype e.g. clear cell versus. non-clear cell

6. Safety and tolerability data reporting for first line sunitinib

Second line:

1. What is the OS of all patients in second line with axitinib, and stratified by MSKCC risk (favourable, intermediate, poor)?

2. What is the duration of therapy with axitinib in second line (using TTD) for all patients and stratified by MSKCC risk (favourable, intermediate, poor)

3. ORR

4. Duration of objective response (CR or PR)

5. Examine factors that predict duration of TTD, e.g. risk stratification, or individual/grouped parameters that comprise the prognostic classification systems

   1. Less than one year from time of diagnosis
   2. Karnovsky performance status less than 80%
   3. Haemoglobin less than the lower limit of normal (e.g. less than 12 g/dl)
   4. Serum calcium great than the upper limit of normal (e.g. 10 mg/dl or : 2.5 mmol/l)
   5. Neutrophil greater than the upper limit of normal (e.g. greater than 7.0 x109 dl)
   6. Platelets greater than the upper limit of normal (e.g. greater than 400 000)
   7. Lactate dehydrogenase greater than 1.5 times the upper limit of normal
   8. Fuhrmann grade of tumour
   9. Tumour subtype e.g. clear cell vs. non-clear cell

6. Safety and tolerability reporting for second line axitinib

The objectives listed below will also be assessed as exploratory analyses for various patient subgroups of interest, and will be conducted if sufficient numbers of patients are available:

1. Axitinib PFS and OS, as a second line therapy following sunitinib, pazopanib, or following other Tyrosine kinase inhibitors (e.g. sorafenib)
2. Axitinib PFS and OS as a third line therapy
3. Axitinib PFS and OS post-immunotherapy (IO), taking into consideration 2nd and 3rd therapy lines, following all IO therapy options, E.g. atezolizumab/bevacizumab, nivolumab/ipilumimab, nivolumab, interleukin-2
4. For the post-sunitinib axitinib cohort: What was the duration of sunitinib therapy before patients transitioned to axitinib?
5. For the post-pazopanib axitinib cohort: What was the duration of sunitinib therapy before patients transitioned to axitinib?
6. Is the duration of therapy on first line sunitinib and/or pazopanib related to duration of therapy for second line axitinib?

Enrollment: 684 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Over the age of 18 years
2. Diagnosis of renal cell carcinoma
3. Treatment with sunitinib and/or axitinib
4. 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:

1. Under the age of 18 years
2. Diagnosis other than renal cell carcinoma
3. No treatment with sunitinib and/or axitinib

Trial design

684 participants in 1 patient group

Patients with advanced RCC

Description:

Patients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic)

Treatment:

Drug: Sunitinib

Drug: Axitinib