Trial Profile
A Prospective Trial of OKN-007 for Diffuse Intrinsic Pontine Glioma (DIPG) in pediatric patients
Status:
Planning
Phase of Trial:
Phase I/II
Latest Information Update: 23 Jul 2021
Price :
$35
*
At a glance
- Drugs Disufenton (Primary)
- Indications Diffuse intrinsic pontine glioma
- Focus Adverse reactions
- Sponsors Oblato
Most Recent Events
- 19 Jul 2021 According to an Oblato media release, the company is in discussion for this trial with a consortium consisting of pediatric cancer hospitals.
- 09 Dec 2020 According to an Oblato media release, DIPGs nonclinical studies using OKN-007 have been recognized as supportive to this proposed phase 1/2 trial plan for DIPG and were also fully accepted by the FDA during the meeting.If the treatment shows efficacy in the clinical study for DIPG, the company will be able to apply for an NDA after the trial is completed.
- 09 Dec 2020 According to an Oblato media release, through this FDA meeting, the company obtained consent from the FDA on important matters, such as patient population, starting dose, approach for dose escalation, and criteria for evaluating disease response.The FDA also gave detailed advice on pharmacokinetic assessment and standard of care radiation therapy during the clinical study.