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NCT03163667 · ClinicalTrials.gov registry record · Phase 2
CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC)
A Phase 2 study of Clear Cell Renal Cell Carcinoma, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT03163667: Completed Phase 2 study of Clear Cell Renal Cell Carcinoma, sponsored by Calithera Biosciences.
NCT03163667 is a Phase 2 study of Clear Cell Renal Cell Carcinoma that has completed, run by Calithera Biosciences. The registered enrollment target is 69 participants, below the 202-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03163667, a Phase 2 study of Clear Cell Renal Cell Carcinoma, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG everolimus
- DRUG CB-839
Study Locations (20)
California
- Los Angeles Hematology Oncology Medical Group - Los Angeles
- UCLA Department of Medicine - Hematology/Oncology - Los Angeles
- Stanford Cancer Center - Stanford
Florida
- Florida Cancer Specialists- South - Fort Myers
- Florida Cancer Specialists- North - St. Petersburg
Georgia
- University Cancer & Blood Center, LLC - Athens
- Northwest Georgia Oncology Centers, P.C. - Marietta
Maryland
- Anne Arundel Medical Center Oncology and Hematology - Annapolis
- University of Maryland, Greenebaum Comprehensive Cancer Center - Baltimore
Missouri
- Mercy Clinic Oncology & Hematology - Joplin
- SCRI HCA Midwest - Kansas City
Arizona
- The University of Arizona Cancer Center - Tucson
Arkansas
- Highlands Oncology Group - Rogers
Idaho
- St. Luke's Mountain States Tumor Institute - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2017-09-06 |
| Est. Completion | 2020-06-01 |
| Phase | Phase 2 |
What the finished NCT03163667 record still lists
NCT03163667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 202-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03163667 names 20 study sites across 14 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03163667 about?
NCT03163667 is a clinical study titled "CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC)". 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 ...
What is the current status of trial NCT03163667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2017-09-06. Estimated completion is 2020-06-01.
What conditions does trial NCT03163667 study?
This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma.
What interventions are being tested in trial NCT03163667?
The interventions under investigation include: Placebo (DRUG), everolimus (DRUG), CB-839 (DRUG).
Who is sponsoring clinical trial NCT03163667?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03163667 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03163667's enrollment target sits among peer trials
69 26th of 45 higher than 20 of 45 other Clear Cell Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clear Cell Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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