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NCT03455270 · ClinicalTrials.gov registry record · Phase 1
G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer
A Phase 1 study, sponsored by G1 Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT03455270 is a Phase 1 study that has completed, run by G1 Therapeutics. The registered enrollment target is 107 participants.
The verdict
NCT03455270, a Phase 1 study, has completed, sponsored by G1 Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study Summary
This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer. The study is an open-label design, consisting of 3 parts: dose-finding portion including food effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with palbociclib expansion portion (Part 3). All parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 184 patients may be enrolled in the study.
Interventions
- DRUG Palbociclib
- DRUG G1T48
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2022-09-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03455270
The ClinicalTrials.gov registry entry for NCT03455270 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 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 2 interventions - of which Palbociclib is the first listed.
NCT03455270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03455270 about?
NCT03455270 is a clinical study titled "G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer". This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast can...
What is the current status of trial NCT03455270?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2018-05-09. Estimated completion is 2022-09-29.
What interventions are being tested in trial NCT03455270?
The interventions under investigation include: Palbociclib (DRUG), G1T48 (DRUG).
Who is sponsoring clinical trial NCT03455270?
This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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