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NCT03455829 · ClinicalTrials.gov registry record · Phase 1

G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer

A Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by G1 Therapeutics.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
8
Study locations

NCT03455829 is a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer that has completed, run by G1 Therapeutics. The registered enrollment target is 30 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 5 states.

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The verdict

NCT03455829, a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, has completed, sponsored by G1 Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
8
Study locations

Study Summary

This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer. The study was an open-label design, planned to consist of 2 parts: a safety, pharmacokinetic, and dose-finding portion (Part 1), and a randomized portion (Part 2). Both parts were to include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 144 patients were planned to be enrolled in the study.

Conditions Studied

Non-Small Cell Lung Cancer Lung Cancer Carcinoma, Non-Small Cell Lung

Interventions

  • DRUG Osimertinib
  • DRUG G1T38

Study Locations (8)

California

  • Beverly Hills Cancer Center - Beverly Hills
  • UCLA Medical Center, Division of Hematology/Oncology/Clinical Research Unit - Santa Monica
  • St Joseph Heritage Healthcare - Santa Rosa

Florida

  • Sylvester Comprehensive Cancer Center/University of Miami Miller School of Medicine Fox Building, Suite 200 G - Miami
  • Mofitt Cancer Center - Tampa

Michigan

  • Univ. of Michigan Hospitals - Ann Arbor

Virginia

  • Virginia Cancer Specialists - Fairfax

Wisconsin

  • Froedtert Hospital & the Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2018-03-29
Est. Completion 2022-02-14
Phase Phase 1

Sponsor

G1 Therapeutics

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03455829

The ClinicalTrials.gov registry entry for NCT03455829 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The listed sponsor is G1 Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib is the first listed.

NCT03455829 reports 8 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Michigan.

Frequently Asked Questions

What is clinical trial NCT03455829 about?

NCT03455829 is a clinical study titled "G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer". This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer. The study was an open-label design, planned to consist of 2 parts: a safety, pharmacokinetic, and...

What is the current status of trial NCT03455829?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-03-29. Estimated completion is 2022-02-14.

What conditions does trial NCT03455829 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Lung Cancer, Carcinoma, Non-Small Cell Lung.

What interventions are being tested in trial NCT03455829?

The interventions under investigation include: Osimertinib (DRUG), G1T38 (DRUG).

Who is sponsoring clinical trial NCT03455829?

This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03455829 being conducted?

This trial has 8 study locations across California, Florida, Michigan, Virginia, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.