Diffuse Midline Gliomas (DMGs) including Diffuse Intrinsic Pontine Gliomas (DIPGs)
Conditions
Brief summary
The primary efficacy endpoint for both Cohorts 1 and 2 is progressionfree survival at 6 months (PFS6). PFS6 is defined as the percentage of participants alive and free from progression at 6 months (26 weeks) after the initiation of the combination of the ONC201 with a novel agent given in the maintenance phase of therapy., The primary efficacy endpoint in Cohort 3 is overall survival at 7 months (OS7). OS7 is defined as the percentage of participants alive at 7 months (30 weeks) after the initiation of the combination of ONC201 with a novel agent given in the maintenance phase of therapy.
Sponsors
Prinses Maxima Centrum voor Kinderoncologie B.V.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint for both Cohorts 1 and 2 is progressionfree survival at 6 months (PFS6). PFS6 is defined as the percentage of participants alive and free from progression at 6 months (26 weeks) after the initiation of the combination of the ONC201 with a novel agent given in the maintenance phase of therapy., The primary efficacy endpoint in Cohort 3 is overall survival at 7 months (OS7). OS7 is defined as the percentage of participants alive at 7 months (30 weeks) after the initiation of the combination of ONC201 with a novel agent given in the maintenance phase of therapy. | — |
Countries
Netherlands
Outcome results
None listed