A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with hormone receptor-positive/HER2-negative (HR+/HER2-) advanced or metastatic breast cancer.

Overview

No summary available.

Registry

who.int

Start Date

January 3, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•1\. Written informed consent provided
•2\. Females 18 years old and greater (at the time of written consent)
•3\. Histologically or cytologically confirmed diagnosis of advanced or metastatic adenocarcinoma of the breast.
•4\. Documentation of ER\-positive and/or PR\-positive tumor based on local testing of the most recent tumor biopsy
•5\. Documentation of HER2\-negative tumor based on local testing of the most recent tumor biopsy
•6\. Provision of mandatory screening fresh tumor biopsy sample during the screening period.
•a. Screening biopsy can be waived if a biopsy was collected within 3 months prior to first dose of study drug and was collected after the last anti\-cancer treatment before coming into this study.
•b. Subjects with inaccessible site of biopsy or who have a significant medical risk of obtaining the biopsy should be discussed with the Medical Monitor if they can qualify.
•c. Bone biopsies are not acceptable. Biopsies should be obtained from bone with metastatic soft\-tissue component. Subjects with bone only disease may be enrolled upon review by Medical Monitor.
•7\. History of prior therapy that satisfies one of the following criteria:

•1\. Prior therapy with any BET inhibitor, any selective estrogen receptor degrader (SERD) including fulvestrant, or inhibitors of the PI3K/AKT/mTOR pathway.
•2\. Prior therapy with more than one line of cytotoxic chemotherapy following diagnosis of advanced/metastatic disease.
•3\. \=3 lines of systemic anti\-cancer therapy in the advanced or metastatic setting
•a. Prior systemic anti\-cancer therapy (cytotoxic chemotherapy, hormonal, CDK4/6 inhibitor therapies) in the neoadjuvant/adjuvant setting does not count toward the lines of therapy.
•4\. Recent prior therapy, defined as:
•· Any investigational or approved non\-biologic anti\-cancer drug within 14
•days or five half\-life (whichever is greater) prior to the first dose of GSK525762 and fulvestrant.
•· Any nitrosoureas or mitomycin C within 42 days prior to the first dose of GSK525762 and fulvestrant
•· Any anti\-cancer biologic agents within 42 days prior to the first dose of GSK525762 and fulvestrant
•· Any radiotherapy within 14 days prior to the first dose of GSK525762 and fulvestrant. If the subject received radiotherapy \<90 days prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.