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NCT03965845 · ClinicalTrials.gov registry record · Phase 1
A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors
A Phase 1 study, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT03965845: Completed Phase 1 study, sponsored by Calithera Biosciences.
NCT03965845 is a Phase 1 study that has completed, run by Calithera Biosciences. The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03965845, a Phase 1 study, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4/6 Inhibitor, palbociclib in participants with advanced/metastatic solid tumors.
Primary Outcome
Number of participants with treatment related adverse events as assessed by CTCAE v5.0
Interventions
- DRUG Telaglenestat (CB-839)
- DRUG Palbociclib Oral Capsule or Tablet [Ibrance]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2021-09-24 |
| Phase | Phase 1 |
What the finished NCT03965845 record still lists
NCT03965845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Telaglenestat (CB-839) is the first listed.
NCT03965845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03965845 about?
NCT03965845 is a clinical study titled "A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors". This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4/6 Inhibitor, palbociclib in participants with advanced/metastatic solid tumors.
What is the current status of trial NCT03965845?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2019-06-25. Estimated completion is 2021-09-24.
What interventions are being tested in trial NCT03965845?
The interventions under investigation include: Telaglenestat (CB-839) (DRUG), Palbociclib Oral Capsule or Tablet [Ibrance] (DRUG).
Who is sponsoring clinical trial NCT03965845?
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 NCT03965845's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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