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Tyrosine Kinase Inhibitor

Axitinib for Renal Cell Carcinoma

Phase 2

Waitlist Available

Led By Moshe Ornstein, MD, MA

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months of treatment and approximately 1 year of follow-up

Awards & highlights

Study Summary

This trial is testing a different way to decide what dose of a drug, axitinib, each patient with advanced kidney cancer should receive based on the side effects they experience.

Eligible Conditions

Renal Cell Carcinoma Metastatic

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months of treatment and approximately 1 year of follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months of treatment and approximately 1 year of follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months of treatment and approximately 1 year of follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Median Progression-free Survival

Secondary outcome measures

Objective Response Rate (ORR)

Patients With Complete Response

Patients With Partial Response

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02129647

30%

Mucositis

10%

Fatigue

10%

Rash

10%

nausea

100%

80%

60%

40%

20%

Study treatment Arm

Axitinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: AxitinibExperimental Treatment1 Intervention

All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

2020

Completed Phase 2

~3050

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,870 Total Patients Enrolled

Moshe Ornstein, MD, MAPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

1 Previous Clinical Trials

29 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are permitted to register for the study at its peak?

"This study is not currently recruiting. It was initially posted on December 30th, 2015 and recently updated on June 1st, 2022. Other clinical trials searching for patients with carcinoma renal cell or in need of Axitinib treatment are available; there are 354 studies related to the former and 48 related to the latter."

Answered by AI

What prior investigations have been done involving Axitinib?

"Back in 2011, the University of Texas MD Anderson Cancer Center first explored axitinib. There have been 79 studies and trials completed since then; presently there are 48 ongoing clinical investigations concentrated around Duarte, California."

Answered by AI

Is the enrollment period still open for this clinical trial?

"The trial in question is no longer accepting participants; it was initially posted on December 30th 2015 and last modified June 1st 2022. For those still looking for a medical study, 354 trials involving carcinoma, renal cell are recruiting patients at present and 48 of those studies require Axitinib treatments specifically."

Answered by AI

Is this groundbreaking research the first of its kind in its field?

"As of right now, 48 Axitinib research studies are located in 385 cities across 30 nations. The initial trial for this drug began in 2011 and was sponsored by Pfizer; it necessitated 39 volunteers and concluded with a Phase 2 FDA approval. Since its inception 9 years ago, 79 tests have been finished."

Answered by AI

How extensive is the geographical scope of this study's management?

"Presently, this clinical trial is running in 4 distinct sites. These locations include Duarte, Cleveland and Nashville among other cities. It could be beneficial to select the nearest site to reduce travel expenses if you become a participant of the study."

Answered by AI

Has the FDA approved Axitinib for therapeutic use?

"Axitinib's safety has been partially validated in a Phase 2 clinical trial, thus warranting it a score of two on our three-tier scale. As this is an exploratory study, no data exists regarding the drug's efficacy."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Individualised Axitinib Regimen for Patients with Metastatic Renal Cell Carcinoma After Treatment with Checkpoint Inhibitors: A Multicentre, Single-arm, Phase 2 Study

Ornstein, Moshe C, Sumanta K Pal, Laura S Wood, Jackie M Tomer, Brian P Hobbs, Xuefei S Jia, Kimberly D Allman, et al.. 2019. “Individualised Axitinib Regimen for Patients with Metastatic Renal Cell Carcinoma After Treatment with Checkpoint Inhibitors: A Multicentre, Single-arm, Phase 2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30513-3.

clinicaltrials.govStudy

Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer

2015. "Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02579811.