View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
February 28, 2022

Kazia Therapeutics begins Phase II trial of paxalisib for glioblastoma in US

The open-label, two-arm trial will analyse the efficacy of paxalisib plus a ketogenic diet and metformin for glioblastoma.

Kazia Therapeutics has commenced a Phase II clinical trial of its investigational new drug, paxalisib, along with metformin and a ketogenic diet to treat recently diagnosed and recurrent glioblastoma, a type of primary brain cancer.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

The trial was launched at Weill Cornell Medicine in the US, with the first subject initiated and a second participant in the screening stage.

Licenced by Kazia from Genentech in 2016, paxalisib is a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway.

The open-label, two-arm trial will analyse the efficacy of paxalisib in combination with a ketogenic diet and metformin in patients with glioblastoma.

Cohort 1 of the trial will have subjects with recently detected glioblastoma with unmethylated MGMT promotor status.

Cohort 2 will enrol individuals with recurrent glioblastoma, irrespective of the methylation status of their MGMT promotor and have progressed following standard-of-care treatment.

Subjects in both cohorts will be given paxalisib plus metformin and a ketogenic diet.

Each arm will have two stages with nearly 16 subjects enrolled in the initial stage to identify initial signs of activity.

Nearly 15 subjects will be enrolled in the second confirmatory stage on confirming the activity.

The proportion of subjects who are alive and progression-free at six months will be the primary endpoint of the trial.

Apart from safety and efficacy, the trial will evaluate various metabolic, pharmacodynamic and new radiographic imaging biomarkers that could aid research and clinical practice in the future.

The company intends to conclude subject recruitment in the second half of CY2023.

Kazia Therapeutics CEO Dr James Garner said: “This important milestone kicks off an exciting year for Kazia, with at least six potential data read-outs anticipated over the course of 2022.

“The GBM AGILE study continues to progress well, and additional studies, such as this one, have the potential to substantially extend and enhance the use of paxalisib in clinical practice.”

The commencement of the latest trial for glioblastoma treatment takes the number of trials of paxalisib underway in brain cancer to a total of eight.

In December last year, the company reported positive data from a Phase II trial of paxalisib as a first-line therapy to treat glioblastoma.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena