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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 is a Phase 3 study that has completed, run by G1 Therapeutics. The registered enrollment target is 194 participants.

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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.

Interventions

  • DRUG Carboplatin
  • DRUG Placebo
  • DRUG Gemcitabine
  • DRUG Trilaciclib

Trial Details

FieldValue
Enrollment Target 194 participants
Start Date 2021-05-14
Est. Completion 2024-05-24
Phase Phase 3

Sponsor

G1 Therapeutics

12 total trials

What the Registry Record Tells You About NCT04799249

The ClinicalTrials.gov registry entry for NCT04799249 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is G1 Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.

NCT04799249 reports 0 study locations.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.