Trials / Completed
CompletedNCT03163667
CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC)
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Everolimus (CBE) vs. Placebo With Everolimus (PboE) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Calithera Biosciences, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | oral tablets |
| DRUG | CB-839 | oral tablets |
| DRUG | everolimus | oral tablets |
Timeline
- Start date
- 2017-09-06
- Primary completion
- 2019-04-26
- Completion
- 2020-06-01
- First posted
- 2017-05-23
- Last updated
- 2022-09-15
- Results posted
- 2022-09-15
Locations
38 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03163667. Inclusion in this directory is not an endorsement.