G1T48, an Oral SERD, in ER-Positive, HER2-Negative Advanced Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:May 9, 2018
End Date:May 2022
Contact:G1 Therapeutics Clinical Contact
Email:clinicalinfo@g1therapeutics.com
Phone:919-213-9835

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A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

This is a study to investigate the potential clinical benefit of G1T48 as an oral selective
estrogen receptor degrader (SERD) in patients with estrogen receptor-positive, HER2-negative
metastatic breast cancer.

The study is an open-label design, consisting 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, 96 patients will be
enrolled in the study.


Inclusion Criteria:

- For Part 1, postmenopausal women only

- For Part 2, any menopausal status

- Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable
to curative therapy

- For Part 1, prior treatment with less than 4 prior lines of chemotherapy

- For Part 2, prior treatment with less than 2 prior line of chemotherapy

- Prior treatment with less than 4 prior endocrine therapies for metastatic breast
cancer

- 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

- Progressed after the end of prior aromatase inhibitor therapy for
advanced/metastatic breast cancer

- For Part 1, evaluable or measurable disease

- For Part 2, measurable disease as defined by RECIST, Version 1.1 including bone-only
disease

- ECOG performance status 0 to 1

- Adequate organ function

Exclusion Criteria:

- Prior treatment with SERMs or SERDs within 5 weeks of first G1T48 dose

- Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or
leptomeningeal disease

- Anticancer therapy within 14 days of first G1T48 dose or within 28 days for
antibody-based therapy

- Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous
radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow

- Prior hematopoietic stem cell or bone marrow transplantation
We found this trial at
3
sites
Brussels,
Principal Investigator: Philippe Aftimos, MD
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Carey Anders, MD
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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Oklahoma City, Oklahoma 73104
Principal Investigator: Susanna Ulahannan, MD
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Oklahoma City, OK
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