A Phase 2 Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease
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|ClinicalTrials.gov Identifier: NCT02915783|
Recruitment Status : Active, not recruiting
First Posted : September 27, 2016
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Clear Cell Renal Cell Carcinoma (nccRCC)||Drug: lenvatinib Drug: everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Multicenter, Phase 2 Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease|
|Actual Study Start Date :||February 20, 2017|
|Estimated Primary Completion Date :||April 18, 2019|
|Estimated Study Completion Date :||April 18, 2019|
Experimental: lenvatinib 18 mg/day and everolimus 5 mg/day
Participants will receive initial doses of lenvatinib 18 milligrams per day (mg/day) (one 10-mg capsule and two 4-mg capsules) and everolimus 5 mg/day (5-mg tablets). Capsules and tablets are to be taken orally in immediate succession once a day (QD), and dosing is recommended to occur at approximately the same time each morning (consistently either with or without food).
4 mg and 10 mg capsules
5 mg tablets
- Overall response rate (ORR) [ Time Frame: up to 6 months ]ORR is defined as the proportion of participants who have a best overall response (BOR) of complete response (CR) or partial response (PR). CR is defined as the disappearance of all target and non-target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum diameters.
- Progression-free survival (PFS) [ Time Frame: up to 6 months ]PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurs first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded at Baseline or during treatment. The sum must also have an absolute increase of ≥5 mm.
- Overall survival (OS) [ Time Frame: up to 6 months ]OS is defined as the time from the date of the first dose of study drug until the date of death from any cause.
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): NCT02915783
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02214|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Texas|
|Dallas, Texas, United States, 75254|
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|