Clinical Trial: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 1/2 Safety, Pharmacokinetic, and Antitumor Activity Study of G1T38 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast

Brief Summary:

This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer.

The study is an open-label design, consists 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, 102 patients will be enrolled in the study.


Detailed Summary:
Sponsor: G1 Therapeutics, Inc.

Current Primary Outcome:

  • Dose Limiting Toxicity [ Time Frame: Week 1 Day 1-Week 5 Day 1 ]
  • Recommended Phase 2 dose [ Time Frame: 14 months ]
  • Recommended Phase 2 dose interval [ Time Frame: 14 months ]
    Twice-Daily or Once-Daily dosing
  • Number of Treatment Related Adverse Event, including Abnormal Laboratory Events [ Time Frame: 36 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 up to 36 months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tumor response based on RECIST, Version 1.1 [ Time Frame: 30 months ]
  • Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Maximum Plasma Concentration (Cmax) [ Time Frame: Week 1 Day 1-Week 9 Day 1 ]
  • Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Area under Curve - plasma concentration (AUC) [ Time Frame: Week 1 Day 1-Week 9 Day 1 ]
  • Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Plasma: terminal half life (T1/2) [ Time Frame: Week 1 Day 1-Week 9 Day 1 ]
  • Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Plasma - Volume of distribution [ Time Frame: Week 1 Day 1-Week 9 Day 1 ]
  • Progression free survival (PFS) [ Time Frame: 36 months ]
  • Overall survival (OS) [ Time Frame: 48 months ]


Original Secondary Outcome: Same as current

Information By: G1 Therapeutics, Inc.

Dates:
Date Received: November 29, 2016
Date Started: January 2017
Date Completion: December 2020
Last Updated: May 1, 2017
Last Verified: March 2017