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.
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
- SECONDARY ID:
2016-001485-29
- NCT ID:
NCT02983071
Conditions
- Carcinoma, Ductal, Breast
- Breast Cancer
- Breast Neoplasm
Interventions
Drug | Synonyms | Arms |
---|
G1T38 | lerociclib | Once-Daily G1T38 Dosing |
Fulvestrant | Faslodex | Once-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.
Trial Arms
Name | Type | Description | Interventions |
---|
Once-Daily G1T38 Dosing | Experimental | G1T38 (lerociclib) orally (once daily) in combination with fulvestrant. | |
Twice-Daily G1T38 Dosing | Experimental | G1T38 (lerociclib) orally (twice daily) in combination with 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: | Active, not 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
October 23, 2020