Study of Dasatinib in Combination With Everolimus for Children and Young Adults With Gliomas Harboring PDGFR/FGFR 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 : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioma||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/FGFR Alterations|
|Actual Study Start Date :||November 17, 2017|
|Estimated Primary Completion Date :||December 1, 2024|
|Estimated Study Completion Date :||December 1, 2025|
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 dailyDrug: Everolimus
3.0 mg/m2, with titration of dosing after first cycle to keep trough level of 5-15 ug/ml
- Proportion of patients alive without progression at 1 year [ Time Frame: 1 Year ]The primary endpoint is Progression Free Survival Rate (PFS). Progression will be defined as 25% increase in the size of the tumor or appearance of new lesions.
- Proportion of patients alive without progression at 2 years [ Time Frame: 2 Years ]The primary endpoint is Progression Free Survival Rate (PFS). Progression will be defined as 25% increase in the size of the tumor or appearance of new lesions.
- The proportion of patients that respond to treatment [ 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.
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. 734-936-9814 email@example.com|
|Principal Investigator: Carl Koschmann, M.D.|
|Principal Investigator:||Carl Koschmann, M.D.||University of Michigan Cancer Center|