Alliance will launch a multi-centre phase II study to investigate the potential use of Kazia's investigational new drug, GDC-0084, alongside several other targeted cancer therapies, in the treatment of brain metastases (cancer that has spread to the brain).
https://finance.yahoo.com/news/positive-data-phase-iia-trial-022900914.html
The Alliance study, also known as A071701, is expected to recruit up to 150 patients in total, all of whom will have cancer that has spread to the brain. Only patients with a genetic alteration in the PI3K pathway will receive GDC-0084, and it is expected that approximately one third of the total patients will be in this group. Patients with other genetic mutations will be allocated to receive either abemaciclib, a CDK inhibitor, also known as Verzenio™, that is manufactured by Eli Lilly and has been approved by FDA for the treatment of certain forms of breast cancer, or entrectinib, a Trk/ALK inhibitor manufactured by Genentech, which has not yet been approved by FDA.
Key Points
- Alliance will initiate an open-label phase II study in patients with brain metastases.
- Depending on the genetic profile of their tumor, patients will be allocated to receive either abemaciclib (Eli Lilly), entrectinib (Genentech), or GDC-0084 (Kazia Therapeutics).
- The trial is expected to recruit up to 150 patients in multiple centers across the US.
- The trial will be led by Alliance, with Kazia providing support including study drug and a financial grant.
- Initiation of this study brings the total number of ongoing clinical trials with GDC-0084 to four, each in different forms of brain cancer.
Up to 30% of patients with metastatic cancer will develop secondary tumors (metastases) in the brain, and it is estimated that there are approximately 200,000 new cases of brain metastases each year in the United States alone. Treatment options remain limited, and average survival of patients with brain metastases ranges from 3 to 27 months, depending on factors such as the location of the original tumor.
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