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 ER+ breast cancer.

Overview

No summary available.

Registry

who.int

Start Date

August 10, 2017

End Date

July 19, 2021

Last Updated

4 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\. History of prior therapy that satisfies one of the following criteria:
•a. AI failures: disease that relapsed during treatment or within 12 months of completion of adjuvant therapy with an AI, OR disease that progressed during treatment with an AI for advanced/metastatic disease. Prior ovarian suppression and/or tamoxifen are allowed as long as other criteria are met.
•b.CDK 4/6 inhibitor plus letrozole failures: disease that progressed during treatment with the combination of a CDK4/6 inhibitor plus letrozole, for advanced/metastatic disease. Prior ovarian suppression and/or tamoxifen are allowed as long as other criteria are met.
•7\. Documented progression on last line of systemic anti\-cancer therapy is required.
•8\. Any menopausal status

•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
•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.
•· Any major surgery within 28 days prior to the first dose of GSK525762 and fulvestrant
•5\.Concomitant active malignancy other than ER\+BC