To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma

NCT04682587 | Completed Results FDA Drug

• 1 other identifier: A4061097
• Study Type: observational
• Target: 481
• Locations: 1 country
• Sites: 1

Brief Summary

To assess how dose reductions or treatment interruptions related to axitinib can be implemented to manage and resolve adverse events occurring among patients with advanced renal cell carcinoma treated with first-line axitinib in combination with avelumab or pembrolizumab

Conditions

Renal Cell Carcinoma

Keywords

Advanced Renal Cell Carcinoma (aRCC)

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Different Type of Adverse Events

  An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

  Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

• Number of Participants With Serious Adverse Events

  AE was considered serious when it: resulted in death, life-threatening, requires in-participant hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may jeopardize the participant or may require intervention to prevent one of the outcomes listed above. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

  6 months

• Duration From Treatment Initiation to Onset of Adverse Events

  An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. In this outcome measure time from index date to occurrence of incidence of any AE is reported. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

  Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

• Duration of Adverse Events From Onset to Resolution

  The time to resolution from AE onset and from initiation of management strategy was calculated for all AEs experienced including repeated AEs. The time to resolution of AE (from the onset of AE and from the initiation of management strategies) was separately estimated using Kaplan-Meier analysis; median time to event will be reported. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

  Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

• Number of Adverse Events Classified According to Type of Management Strategy

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

  Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

• Duration of Treatment Interruption for Axitinib

  Duration of treatment interruption was calculated as the total days of treatment interruption. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

  Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 month

• Maximum Axitinib Dose Reduction

  Maximum axitinib dose reduction was calculated as the difference between axitinib dose at AE onset and the minimum axitinib dose recorded between the date of AE onset and either the date of AE resolution (if the AE had a reported resolution date) or the end of follow up (if the AE did not have a reported resolution date).Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.

  Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Interventions

Axitinib DRUG

Inlyta, axitinib

Avelumab DRUG

Avelumab, Bavencio

Pembrolizumab DRUG

Pembrolizumab, Keytruda

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

Patients with aRCC

You may qualify if:

• Physicians meeting the following criteria will be invited to participate in the chart review study:
• Specialty in oncology
• Access to complete medical records for at least one patient with advanced RCC who meets the patient eligibility criteria
• Confirmed diagnosis with advanced RCC
• Treated with first-line axitinib/IO combination therapy at or after diagnosis
• Experienced at least one AE (i.e., diarrhea, fatigue, nausea, hypertension, and palmar-plantar erythrodysesthesia \[hand-foot syndrome\]) while treated with axitinib/IO combination therapy
• Age 18 years or older at the time of advanced RCC diagnosis
• Initiated axitinib/IO combination therapy at least 3 months prior to the start date of medical chart abstraction to ensure sufficient follow-up time

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10017, United States

Location

Related Publications (1)

• Zakharia Y, Huynh L, Du S, Chang R, Pi S, Sundaresan S, Duh MS, Zanotti G, Thomaidou D. Impact of Therapy Management on Axitinib-Related Adverse Events in Patients With Advanced Renal Cell Carcinoma Receiving First-Line Axitinib + Checkpoint Inhibitor. Clin Genitourin Cancer. 2023 Oct;21(5):e343-e351. doi: 10.1016/j.clgc.2023.03.017. Epub 2023 Apr 3.

  PMID: 37087399 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Axitinib; avelumab; pembrolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

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: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 24, 2020
• Study Start: February 24, 2021
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)