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COMPLETED Phase 2

CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC)

NCT03163667 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 69 participants
Start Date 2017-09-06
Est. Completion 2020-06-01
Phase Phase 2

Sponsor

Calithera Biosciences

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03163667

The ClinicalTrials.gov registry entry for NCT03163667 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calithera Biosciences, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03163667 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03163667?

The interventions under investigation include: Placebo (DRUG), everolimus (DRUG), CB-839 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03163667?

This trial is sponsored by Calithera Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial