A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas
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|ClinicalTrials.gov Identifier: NCT03632317|
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioma Diffuse Intrinsic Pontine Glioma||Drug: Panobinostat Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients will be divided into two stratums; newly diagnosed high-grade glioma or DIPG after radiation (stratum A) and recurrent/progressive glioma (grade II-IV, including DIPG) (stratum B).|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas Harboring H3.3 or H3.1 K27M Mutation|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||September 2025|
|Estimated Study Completion Date :||September 2025|
Experimental: Panobinostat and Everolimus
Panobinostat daily M, W, F for 2 weeks every 28 days for the first cycle (28 days). After first cycle Panobinostat daily M, W, F for 2 weeks every 28 days combined with Everolimus daily.
- Median Progression Free Survival (PFS) at 1 Year [ Time Frame: 1year ]Median PFS at 1 year for stratum A will be measured. Progression is defined as > 25% increase in the size of the tumor or appearance of new lesions.
- Median Progression Free Survival (PFS) at 2 Years [ Time Frame: 2years ]Median PFS at 1 year for stratum A will be measured. Progression is defined as > 25% increase in the size of the tumor or appearance of new lesions.
- Overall Survival at 1Year [ Time Frame: 1year ]The proportion of patients alive at 1 year for stratum A.
- Overall Survival at 2Years [ Time Frame: 2years ]The proportion of patients alive at 2 years for stratum A.
- Overall Response Rate (ORR) After Two Cycles of Panobinostat + Everolimus [ Time Frame: 84 Days ]Overall Response Rate (ORR) After Two Cycles of Panobinostat + Everolimus for stratum B. Overall response is defined as a partial or complete response. Partial response is defined as a ≥50% decrease in size of tumor in comparison to baseline measurements. Complete response is defined as the disappearance of all abnormal signal. This includes return to normal size of the brainstem for brainstem lesions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632317
|Contact: Carl Koschmann, MDemail@example.com|
|United States, Michigan|
|University of Michigan Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Carl Koschmann, M.D. 734-615-2736 firstname.lastname@example.org|
|Principal Investigator: Carl Koschmann, MD|
|Principal Investigator:||Carl Koschmann, MD||University of Michigan Rogel Cancer Center|