Overview

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

Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
G1 Therapeutics, Inc.
Treatments:
Estradiol
Fulvestrant
Hormones
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