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NCT04799249 · ClinicalTrials.gov registry record · Phase 3
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
A Phase 3 study, sponsored by G1 Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
NCT04799249: Completed Phase 3 study, sponsored by G1 Therapeutics.
NCT04799249 is a Phase 3 study that has completed, run by G1 Therapeutics. The registered enrollment target is 194 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04799249, a Phase 3 study, has completed, sponsored by G1 Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
Study Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.
Primary Outcome
(Cohort 1):To evaluate the effect of trilaciclib on overall survival (OS) compared with placebo in patients receiving first-line gemcitabine and carboplatin.
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Gemcitabine
- DRUG Trilaciclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2021-05-14 |
| Est. Completion | 2024-05-24 |
| Phase | Phase 3 |
What the finished NCT04799249 record still lists
NCT04799249 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT04799249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04799249 about?
NCT04799249 is a clinical study titled "Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)". This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNB...
What is the current status of trial NCT04799249?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2021-05-14. Estimated completion is 2024-05-24.
What interventions are being tested in trial NCT04799249?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Gemcitabine (DRUG), Trilaciclib (DRUG).
Who is sponsoring clinical trial NCT04799249?
This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04799249's enrollment target sits among peer trials
194 1395th of 2000 higher than 604 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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