Australian company Kazia Therapeutics has collaborated with the Alliance for Clinical Trials in Oncology Foundation on clinical trials for metastatic brain cancer treatment.
Under the collaboration, the US-based cancer research network will launch a multi-centre Phase II trial to investigate the potential use of Kazia’s investigational new drug, GDC-0084, and several other targeted cancer therapies.
Alliance will initiate an open-label Phase II study, also known as A071701, in patients with brain metastases and allocate them to receive either abemaciclib (Eli Lilly), entrectinib (Genentech), or GDC-0084, depending on the genetic profile of their tumour.
The study will be led by Alliance, with Kazia providing the study drug and a financial grant. It is expected to recruit up to 150 patients in multiple centres across the US.
Initiation of the trial will bring the total number of ongoing clinical trials with GDC-0084 to four.
Kazia Therapeutics CEO Dr James Garner said: “The Alliance study is a ground-breaking research project that aims to investigate several experimental drugs in a single clinical study.
“Patients will be allocated to treatment depending on their tumour’s individual genetic signature, and patients with a mutation affecting the PI3K pathway will be eligible to receive GDC-0084.”
The study is expected to take two years for completion and will be conducted under an ‘investigator IND’ with the US Food and Drug Administration.
Alliance will assume the primary regulatory responsibilities for the study. Implementation of the study is subject to approval from applicable Institutional Review Boards, and completion of contractual formalities.
Recruitment for the study is expected to start in the second half of this year.