Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02579811|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2015
Results First Posted : August 7, 2020
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Cancer||Drug: Axitinib||Phase 2|
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).
- To characterize the objective response rates in patients given axitinib on an individualized dose/schedule.
- To evaluate the tolerability and safety of an alternative method of axitinib titration.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 30, 2015|
|Actual Primary Completion Date :||August 21, 2019|
|Estimated Study Completion Date :||August 21, 2023|
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.
The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
- Median Progression-free Survival [ Time Frame: Up to 18 months ]The primary endpoint of progression-free survival in months (per per RECIST v1.1 criteria) will be estimated using the Kaplan-Meier method. Summary statistics will be provided along with 95% confidence intervals.
- Patients With Complete Response [ Time Frame: Up to 4 months of treatment and approximately 1 year of follow-up ]Tumor Response, defined as overall confirmed objective response, is confirmed complete response (CR) according to the RECIST 1.1 criteria. RECIST 1.1: Complete response (CR) is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
- Patients With Partial Response [ Time Frame: Up to 4 months of treatment and approximately 1 year of follow-up ]Tumor Response, defined as overall confirmed objective response, is confirmed complete response (CR) according to the RECIST 1.1 criteria. RECIST 1.1: Partial response (PR) is defined as a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
- Objective Response Rate (ORR) [ Time Frame: Up to 4 months of treatment and approximately 1 year of follow-up ]ORR as defined by Recist V. 1.1. ORR = (CR + PR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579811
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute|
|Columbus, Ohio, United States, 43210|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Moshe Ornstein, MD, MA||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|