Study of Dasatinib in Combination With Everolimus for Children and Young Adults With Gliomas Harboring PDGFR Alterations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03352427|
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioma High Grade Glioma Pontine Tumors||Drug: Dasatinib Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Dasatinib in Combination With Everolimus for Children With Gliomas Harboring PDGFR Alterations|
|Actual Study Start Date :||December 6, 2017|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Dasatinib = 60 mg/m2 orally twice daily
Everolimus = starting dose of 3.0 mg/m2, with titration of dosing after first cycle to keep everolimus trough level of 5-15 ug/ml
Both agents will be taken daily for 28 day cycles. Cycles will be repeated every 28 days and patients may receive up to 24 cycles.
60 mg/m2 orally twice daily
3.0 mg/m2, with titration of dosing after first cycle to keep trough level of 5-15 ug/ml
- Progression-free survival in participants with newly diagnosed diffuse intrinsic pontine glioma (DIPG) [ Time Frame: 8 months ]Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
- Progression-free survival in participants with newly diagnosed high-grade glioma (HGG) [ Time Frame: 12 months ]Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
- Overall response rate (OR) (partial response or better) in participants with refractory or recurrent glioma [ Time Frame: 56 Days ]The overall response assessment will take into account response in both target and non-target lesions, as well as the appearance of new lesions. Partial Response (PR) will be defined as ≥50% decrease in size of tumor in comparison to baseline measurements. Complete Response (CR) will be defined as The disappearance of all abnormal signal. This includes return to normal size of the brainstem for brainstem lesions.
- Overall Survival [ Time Frame: 1 year ]
- Overall Survival [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352427
|Contact: Carl Koschmann, M.D.||firstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Carl Koschmann, M.D. 734-615-2736 email@example.com|
|Principal Investigator: Carl Koschmann, MD|
|Principal Investigator:||Carl Koschmann, M.D.||University of Michigan Rogel Cancer Center|