Phase I Study of GDC-0084, a Brain-Penetrant PI3 Kinase/mTOR Inhibitor, in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas After Radiation Therapy
Phase of Trial: Phase I
Latest Information Update: 13 Sep 2019
Price : $35 *
At a glance
- Drugs GDC 0084 (Primary)
- Indications Anaplastic astrocytoma; Glioma
- Focus Adverse reactions; Pharmacokinetics
- 13 Sep 2019 According to a Kazia Therapeutics media release, To date, thirteen patients have received treatment with GDC-0084.
- 12 Sep 2019 According to a Kazia Therapeutics media release, St Jude Children's Research Hospital has successfully completed the first stage of this study and determined a maximum tolerated dose (MTD) in the pediatric setting of 27 mg/m2 which is approximately equivalent to the doses currently being explored in adult studies. The safety profile of the drug in children appears to be broadly similar to that in adults and no unexpected findings encountered. The study will now proceed into an expansion cohort.
- 01 Nov 2018 Planned initiation date (estimated date for recruitment of the first subject) changed from 1 Oct 2018 to 1 Nov 2018.