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

Last updated date
Study Location
Pfizer
New York, New York, 10017, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Eligible oncologists will be asked to select up to three patients meeting the following criteria for inclusion in the chart review study:

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


There are no exclusion criteria for this study

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Renal Cell CarcinomaPre-Surgical Sutent in Renal Cell Carcinoma (RCC)
NCT00715442
  1. Houston, Texas
  2. Houston, Texas
ALL GENDERS
0+
years
MULTIPLE SITES
Renal Cell CarcinomaAxitinib Therapy Management Study
NCT04555603
  1. New York, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Renal Cell CarcinomaA Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma
NCT00480935
  1. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title 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
Official Title A Panel-Based Chart Review Study to Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving First-Line Axitinib in Combination With Immune-Oncology Drugs for the Treatment of Advanced Renal Cell Carcinoma
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
Detailed Description

The specific objectives of the study are as follows:

Describe incident adverse events (AEs) experienced among patients with advanced RCC who received first-line axitinib in combination with immuno-oncology (IO) therapies.

  • Type and seriousness of AEs (ie, diarrhea, fatigue, hypertension, nausea, palmar plantar erythrodysesthesia [hand-foot syndrome]).
  • Proportion of patients who experienced repeated AEs.
  • Time from treatment initiation to AE onset, overall and by type and seriousness of AEs.

Among patients with advanced RCC who developed incident AEs while receiving first line axitinib in combination with IO therapies, characterize and describe management strategies for AEs, stratified by type and seriousness of AEs.

  • Proportion of patients who used each of the following management strategies:
  • No action for axitinib and IO therapy;
  • No action for axitinib, but treatment modification for IO therapy (ie, treatment interruption, treatment discontinuation);
  • Axitinib dose reduction, but no action for IO therapy;
  • Axitinib treatment interruption, but no action for IO therapy;
  • Axitinib treatment discontinuation, but no action for IO therapy;
  • Axitinib dose reduction, and treatment modification for IO therapy;
  • Axitinib treatment interruption, and treatment modification for IO therapy;
  • Axitinib treatment discontinuation, and treatment modification for IO therapy.
  • Average axitinib dose reduction (absolute and percentage change), where applicable.
  • Duration of treatment interruption, where applicable.

Assess the frequency of and time to AE resolution (from AE onset and initiation of management strategy, separately) among patients with advanced RCC who developed incident AEs while receiving first-line axitinib in combination with IO therapies according to different management strategies implemented, stratified further by type and seriousness of AEs, as allowed by sample size.

The above objectives will also be conducted for repeated AEs of the same type

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with aRCC
Condition Renal Cell Carcinoma
Intervention
  • Drug: Axitinib
    Inlyta, axitinib
  • Drug: Avelumab
    Avelumab, Bavencio
  • Drug: Pembrolizumab
    Pembrolizumab, Keytruda
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 8, 2021)
500
Original Estimated Enrollment
 (submitted: December 18, 2020)
1
Estimated Study Completion Date January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Eligible oncologists will be asked to select up to three patients meeting the following criteria for inclusion in the chart review study:

  • 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

Exclusion Criteria:

There are no exclusion criteria for this study

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04682587
Other Study ID Numbers A4061097
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021