G1T48, an Oral SERD, in ER-Positive, HER2-Negative Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03455270|
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : September 28, 2018
This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer.
The study is an open-label design, consisting of 2 parts: dose-finding portion (Part 1), and expansion portion (Part 2). Both 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, 96 patients will be enrolled in the study.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Ductal, Breast Breast Cancer Female Breast Neoplasm Breast Cancer||Drug: G1T48||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer|
|Actual Study Start Date :||May 9, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||May 2022|
Experimental: Part 1: Dose Escalation
Patients in Part 1 will receive a single oral dose of G1T48 on Cycle 1 Day -3 and will begin once-daily dosing on Cycle 1 Day 1.
The initial dose cohort shall receive an identified starting dose and subsequent cohorts shall receive higher doses based on the safety and PK data obtained from the previous dose levels.
Experimental: Part 1: Food Effect Cohort
In Part 1, an additional G1T48 cohort of 8 patients may be enrolled to assess the effect of a high-fat meal on the rate and extent of the absorption of G1T48.
Patients will receive a single oral dose of G1T48 on Cycle 1 Day -10 and on Cycle 1 Day -3. Patients will begin G1T48 once-daily dosing on Cycle 1 Day 1.
Experimental: Part 2: Dose Expansion
Patients in Part 2 will receive G1T48 once-daily at the dose determined in Part 1.
- Dose Limiting Toxicity [ Time Frame: Cycle 1 Day -3 to Cycle 1 Day 28 ]
- Recommended Phase 2 dose [ Time Frame: 12 months ]
- Number of Treatment Related Adverse Event, including Abnormal Laboratory Events [ Time Frame: 21 months ]All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all patients receiving study drug from the signing of the informed consent until 30 days after the last dose of study medication.
- Tumor response based on RECIST, Version 1.1 [ Time Frame: 21 months ]
- Effect of food on bioavailability of G1T48 [ Time Frame: Part 1, Cycle 1 Day -10 to Cycle 1 Day 1. ]
- Pharmacokinetics of G1T48 and metabolites: Maximum Plasma Concentration (Cmax) [ Time Frame: Part 1, Cycle 1 Day -3 to Cycle 2 Day 1. Part 2, Cycle 2 Day 1 to Cycle 3 Day 1. ]
- Pharmacokinetics of G1T48 and metabolites: Area under Curve - plasma concentration (AUC) [ Time Frame: Part 1, Cycle 1 Day -3 to Cycle 2 Day 1. Part 2, Cycle 2 Day 1 to Cycle 3 Day 1. ]
- Pharmacokinetics of G1T48 and metabolites: Plasma: terminal half life (T1/2) [ Time Frame: Part 1, Cycle 1 Day -3 to Cycle 2 Day 1. Part 2, Cycle 2 Day 1 to Cycle 3 Day 1. ]
- Pharmacokinetics of G1T48 and metabolites: Plasma - Volume of distribution [ Time Frame: Part 1, Cycle 1 Day -3 to Cycle 2 Day 1. Part 2, Cycle 2 Day 1 to Cycle 3 Day 1. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455270
|Contact: G1 Therapeutics Clinical Contactfirstname.lastname@example.org|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599-7305|
|Principal Investigator: Carey Anders, MD|
|Institut Jules Bordet||Recruiting|
|Brussels, Belgium, 1000|
|Principal Investigator: Philippe Aftimos, MD|
|Leuven, Belgium, 3000|
|Principal Investigator: Patrick Neven, MD|
|VU University Medical Center||Recruiting|
|Amsterdam, Netherlands, 1081 HV|
|Principal Investigator: C. Willimien Menke, MD|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9713 GZ|
|Principal Investigator: Elisabeth de Vries, MD|
|Erasmus Medical Center||Recruiting|
|Rotterdam, Netherlands, 3015 GD|
|Principal Investigator: Agnes Jager, MD|
|Study Director:||Clinical Contact||G1 Therapeutics, Inc.|