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

G

G1 Therapeutics

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Breast Cancer
Breast Neoplasm
Carcinoma, Ductal, Breast

Treatments

Drug: Fulvestrant
Drug: G1T38

Study type

Interventional

Funder types

Industry

Identifiers

NCT02983071
2016-001485-29 (EudraCT Number)
G1T38-02

Details and patient eligibility

About

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.

Enrollment

102 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Once-Daily G1T38 Dosing
Experimental group
Description:
G1T38 (lerociclib) orally (once daily) in combination with fulvestrant.
Treatment:
Drug: G1T38
Drug: Fulvestrant
Twice-Daily G1T38 Dosing
Experimental group
Description:
G1T38 (lerociclib) orally (twice daily) in combination with fulvestrant.
Treatment:
Drug: G1T38
Drug: Fulvestrant

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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