NCT03455270

G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 Alone and in Combination With Palbociclib in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: G1 Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Ductal, Breast
• Breast Cancer Female
• Breast Neoplasm
• Breast Cancer
• Metastatic Breast Cancer
• Advanced Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	G1T48	oral SERD
DRUG	Palbociclib	CDK 4/6 Inhibitor

Timeline

• Start date: 2018-05-09
• Primary completion: 2022-09-29
• Completion: 2022-09-29
• First posted: 2018-03-06
• Last updated: 2022-12-15

Locations

15 sites across 7 countries: United States, Belgium, Bulgaria, Georgia, Moldova, Netherlands, Ukraine

Regulatory

• FDA-regulated drug study