Clinical Trials /

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

NCT02983071

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
  • 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 Cancer After Endocrine Failure

Clinical Trial IDs

  • ORG STUDY ID: G1T38-02
  • NCT ID: NCT02983071

Conditions

  • Carcinoma, Ductal, Breast
  • Breast Cancer
  • Breast Neoplasm

Interventions

DrugSynonymsArms
G1T38Once-Daily G1T38 Dosing
FulvestrantFaslodexOnce-Daily G1T38 Dosing

Purpose

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 Description

Trial Arms

NameTypeDescriptionInterventions
Once-Daily G1T38 DosingExperimentalG1T38 orally (once daily) in combination with fulvestrant.
  • G1T38
  • Fulvestrant
Twice-Daily G1T38 DosingExperimentalG1T38 orally (twice daily) in combination with fulvestrant.
  • G1T38
  • Fulvestrant

Eligibility Criteria

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

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicity
Time Frame:Week 1 Day 1-Week 5 Day 1
Safety Issue:
Description:Twice-Daily or Once-Daily dosing

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:G1 Therapeutics, Inc.

Trial Keywords

  • Breast Cancer
  • CDK 4/6 Inhibitor
  • HER2-Negative
  • HR-Positive
  • HR+
  • HER2-
  • HER2 -ve
  • HER2 +ve

Last Updated

January 7, 2017