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Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer

A Phase II Study of the Efficacy and Safety of Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer After Treatment With Pd-1 or Pd-L1 Inhibitors

NCT02579811•Case Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

Axitinib is a drug which is approved by the FDA for patients with advanced kidney cancer who have already received some treatment. It works by reducing blood flow to a tumor. Axitinib is normally give at 5mg twice per day and sometimes this dose is increased if patients tolerate it. The purpose of this study is to figure out a different way to decide which dose of axitinib each patient should receive based on the side effects they experience.

Detailed Description

Primary objective To determine whether axitinib given on an individualized dose/schedule for metastatic renal cell carcinoma following immunotherapy with PD-1 and PD-L1 Inhibitors leads to improved progression-free survival (PFS). Secondary objectives: 1. To characterize the objective response rates in patients given axitinib on an individualized dose/schedule. 2. To evaluate the tolerability and safety of an alternative method of axitinib titration. 3. To characterize the anti-tumor effect, as measured by change in tumor burden per RECIST 1.1, of axitinib titration performed after initial RECIST PD on axitinib.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed, locally recurrent or metastatic clear cell renal cell carcinoma
•Has received one prior systemic therapy regimen for Metastatic Renal Cell Carcinoma (mRCC) directed against PD-1 and/or PD-L1 which must have been the most recent regimen
•* Prior high-dose interleukin-2 therapy is permitted in addition to anti-PD(L)1 therapy, but is not required
•* Prior bevacizumab or Vascular Endothelial Growth Factor (VEGF) Tyrosine Kinas Inhibitor (TKI) is permitted either in combination with anti-PD(L)1 therapy OR as monotherapy when given PRIOR to anti-PD(L)1 therapy
•* Prior treatment with combined ipilimumab and nivolumab is permitted
•* Prior axitinib in any setting is not permitted
•* A minimum of two weeks since last dose of most recent renal cell cancer therapy assuming resolution of clinically significant treatment-related toxicities to grade 1, baseline, or controlled with supportive medications
•Evidence of measurable disease per RECIST 1.1.
•Karnofsky performance status ≥ 70 %.
•Adequate organ function as defined by:
+8 more criteria

Exclusion Criteria

•Non clear cell Renal Cell Carcinoma (RCC)
•Major surgery within 4 weeks of starting the study treatment.
•Radiation therapy within 2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
•NCI CTCAE Version 4.03 grade 3 hemorrhage within 4 weeks of starting the study treatment.
•Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack.
•Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.03 grade ≥2. Controlled atrial fibrillation is permitted.
•Uncontrolled hypertension (\>160/100 mm Hg despite optimal medical therapy)
•Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, and imaging trials, are allowed.
•Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
•Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
+1 more criteria

Locations (4)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Columbus, Ohio, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Key Dates

Start Date

December 30, 2015

Primary Completion Date

August 21, 2019

Completion Date

June 20, 2023

Last Updated

June 29, 2023

Enrollment

ACTUAL participants

Conditions

Metastatic Renal Cell Cancer

Interventions

Axitinib

DRUG

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

NCT07227415

Carcinoma, Renal CellAdvanced Renal Cell Carcinoma+11 more

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ACTIVE_NOT_RECRUITINGPHASE2

Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer

NCT03092856

Clear Cell Renal Cell CarcinomaMetastatic Renal Cell Cancer+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer

Radiotherapy As an Immunological Booster in Patients with Metastatic Melanoma or Renal Cell Carcinoma Treated with High-dose Interleukin-2

Stereotactic Body Radiation Therapy in Treating Patients With Metastatic or Recurrent Kidney Cancer

Tremelimumab With or Without Cryoablation in Treating Patients With Metastatic Kidney Cancer

Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors