The primary objective of this study is to compare the progression-free survival (PFS) of participants treated with telaglenastat and everolimus versus placebo and everolimus for advanced or metastatic clear cell renal cell carcinoma (ccRCC) previously treated with the following: * At least 2 lines of therapy, including at least 1 vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI) * Radiographic progression of metastatic RCC must have occurred (per investigator assessment) on or after the most recent systemic therapy and within 6 months prior to cycle 1 day 1
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
oral tablets
oral tablets
oral tablets
The University of Arizona Cancer Center
Tucson, Arizona, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
Stanford Cancer Center
Stanford, California, United States
Progression Free Survival (PFS)
PFS was defined as the time from randomization to the date of documented disease progression (assessed by Investigator per Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1) within 2 scheduled scan intervals following previous evaluable radiologic tumor assessment or death for any cause, whichever occurred first. Participants with no documentation of disease progression or death on-study were censored at the date of last available tumor assessment. Progressive Disease (PD) per RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: As of the primary data cutoff date of 26 Apr 2019; maximum duration of follow-up for PFS was 11.2 months.
Overall Survival (OS)
Overall survival is defined as the time from randomization to the date of death from any cause. Participants with no documentation of death on-study were censored at the date at which they were last known to be alive.
Time frame: As of the data cutoff date of 30 Sep 2020; maximum duration of follow-up for OS was 30.4 months.
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Florida Cancer Specialists- South
Fort Myers, Florida, United States
Florida Cancer Specialists- North
St. Petersburg, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States
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