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

February 14, 2023 updated by: G1 Therapeutics, Inc.

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 Cancer After Endocrine Failure

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1330
        • MHAT for Womens Health - Nadezhda OOD
      • Sofia, Bulgaria, 1756
        • Special Hospital For Active Treatment In Oncology
  • Georgia
      • Tbilisi, Georgia, 0112
        • ARENSIA Exploratory Medicine LLC
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2025
        • The Institute Of Oncology
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute
      • London, United Kingdom, NW1 2BU
        • University College London Hospital (UCLH)
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of HR-positive, HER2-negative breast cancer, not amenable to curative therapy
  • Pre- or perimenopausal women can be enrolled if amenable to be treated with goserelin

  • Patients must satisfy 1 of the following criteria for prior therapy:

    • Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor or tamoxifen
    • Progressed during treatment or within 2 months after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer, or prior endocrine therapy for advanced/metastatic breast cancer
    • Received ≤ 2 chemotherapy regimens (Part 1) or ≤ 1 chemotherapy regimen (Part 2) for advanced/metastatic disease
  • For Part 1, evaluable or measurable disease (bone only disease eligible for Part 1 only)
  • For Part 2, measurable disease as defined by RECIST, Version 1.1
  • ECOG performance status 0 to 1
  • Adequate organ function

Exclusion Criteria:

  • For Part 1, prior treatment with fulvestrant
  • For Part 2, prior treatment with any CDK inhibitor or fulvestrant
  • Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
  • Chemotherapy within 21 days of first G1T38 dose
  • Investigational drug within 28 days of first G1T38 dose
  • Concurrent radiotherapy, radiotherapy within 14 days of first G1T38 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow
  • Prior hematopoietic stem cell or bone marrow transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Once-Daily G1T38 Dosing
G1T38 (lerociclib) orally (once daily) in combination with fulvestrant.
Drug: G1T38
Other Names:
  • lerociclib
Drug: Fulvestrant
Other Names:
  • Faslodex
Experimental: Twice-Daily G1T38 Dosing
G1T38 (lerociclib) orally (twice daily) in combination with fulvestrant.
Drug: G1T38
Other Names:
  • lerociclib
Drug: Fulvestrant
Other Names:
  • Faslodex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicity
Time Frame: Week 1 Day 1-Week 5 Day 1
Week 1 Day 1-Week 5 Day 1
Recommended Phase 2 dose
Time Frame: 14 months
14 months
Recommended Phase 2 dose interval
Time Frame: 14 months
Twice-Daily or Once-Daily dosing
14 months
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
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response based on RECIST, Version 1.1
Time Frame: 30 months
30 months
Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Maximum Plasma Concentration (Cmax)
Time Frame: Week 1 Day 1-Week 9 Day 1
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
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
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
Week 1 Day 1-Week 9 Day 1
Progression free survival (PFS)
Time Frame: 36 months
36 months
Overall survival (OS)
Time Frame: 48 months
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G1 Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G1T38-02
  • 2016-001485-29 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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