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NCT03428217 · ClinicalTrials.gov registry record · Phase 2
CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
A Phase 2 study, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 444
- Enrollment target
NCT03428217: Completed Phase 2 study, sponsored by Calithera Biosciences.
NCT03428217 is a Phase 2 study that has completed, run by Calithera Biosciences. The registered enrollment target is 444 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (234% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03428217, a Phase 2 study, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 444 participants
- Enrollment target
Study Summary
Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).
Primary Outcome
PFS is defined as the time from randomization to the occurrence of disease progression as assessed by the IRC using RECIST v1.1 or death from any cause, whichever occurs first. Subjects not experiencing disease progression or death at the time of analysis of PFS will be censored at the date of the last evaluable radiographic disease assessment. RECIST v1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameter
Interventions
- DRUG Placebo
- DRUG Cabozantinib
- DRUG CB-839
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2018-04-24 |
| Est. Completion | 2021-07-16 |
| Phase | Phase 2 |
What the finished NCT03428217 record still lists
NCT03428217 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (234% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03428217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03428217 about?
NCT03428217 is a clinical study titled "CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma". Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).
What is the current status of trial NCT03428217?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 444 participants. The study started on 2018-04-24. Estimated completion is 2021-07-16.
What interventions are being tested in trial NCT03428217?
The interventions under investigation include: Placebo (DRUG), Cabozantinib (DRUG), CB-839 (DRUG).
Who is sponsoring clinical trial NCT03428217?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03428217's enrollment target sits among peer trials
444 89th of 2000 higher than 1,912 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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