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

NCT04033991 | Completed Results FDA Drug

• 1 other identifier: X9001180
• Study Type: observational
• Target: 684
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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)?

Conditions

Carcinoma; Renal Cell

Keywords

Carcinoma;; renal cell;; cancer;; kidney;; sunitinib;; axitinib

Outcome Measures

Primary Outcomes (3)

• Progression Free Survival (PFS)

  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.

  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)

• Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification

  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.

  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)

• Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification

  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.

  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)

Secondary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (7)

• Number of Participants Who Started Systemic Therapy Within 1 Year of Diagnosis

  Baseline (data retrieved and observed retrospectively for approximately 1.2 years)

• Number of Participants With Karnofsky Performance Status (KPS) Less Than 80 Percent (%)

  Baseline (data retrieved and observed retrospectively for approximately 1.2 years)

• Number of Participants With Hemoglobin Less Than Lower Limit of Normal (LLN)

  Baseline (data retrieved and observed retrospectively for approximately 1.2 years)

Study Arms (1)

Patients with advanced RCC

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

Drug: Sunitinib; Drug: Axitinib

Interventions

Sunitinib DRUG

Tyrosine kinase inhibitor, licensed for use in treatment of renal cell carcinoma.

Also known as: Sutent

Patients with advanced RCC

Axitinib DRUG

Tyrosine kinase inhibitor, licensed for use in treatment of renal cell carcinoma.

Also known as: Inlyta

Patients with advanced RCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer UK

London, United Kingdom

Location

Related Publications (1)

• Waddell T, Pillai M, Armitage K, Graham DM, Moran M, Dilleen M, Holmes S, Sleszynska-Dopiera E, Hawkins R. Real-world effectiveness of first- and second-line anti-angiogenesis therapy in RCC: analysis of a UK-based population. Future Oncol. 2024;20(33):2547-2558. doi: 10.1080/14796694.2024.2385882. Epub 2024 Oct 9.

  PMID: 39382446 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma; Neoplasms

Interventions

Sunitinib; Axitinib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 26, 2019
• Study Start: September 27, 2019
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: April 6, 2023
• Results First Posted: February 18, 2022

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)