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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: Completed Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by G1 Therapeutics.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including: * Grade 4 neutropenia * ≥ Grade 3 neutropenic infection/febrile neutropenia * Grade 4 thrombocytopenia * ≥ Grade 3 thrombocytopenia with bleeding * ≥ Grade 3 nonhematologic toxicity (additional criteria for nausea, vomiting, diarrhea, or fatigue: lasting \> 5 days with maximal medical management) * Liver function test abnormalities meeting Hy's Law criteria (aspartate aminotransferase \[AST\] or alani
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2022-02-14 |
| Phase | Phase 1 |
What the finished NCT03455829 record still lists
NCT03455829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower).
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 lists 8 locations in 5 states (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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Where NCT03455829's enrollment target sits among peer trials
30 387th of 454 higher than 58 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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