Trial Outcomes & Findings for Study of Dasatinib in Combination With Everolimus for Children and Young Adults With Gliomas Harboring Platelet-Derived Growth Factor Receptor (PDGFR) Alterations (NCT NCT03352427)
NCT ID: NCT03352427
Last Updated: 2022-10-05
Results Overview
Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
8 months
Results posted on
2022-10-05
Participant Flow
Participant milestones
| Measure |
Dasatinib+Everolimus
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.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Dasatinib in Combination With Everolimus for Children and Young Adults With Gliomas Harboring Platelet-Derived Growth Factor Receptor (PDGFR) Alterations
Baseline characteristics by cohort
| Measure |
Dasatinib+Everolimus
n=3 Participants
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.
|
|---|---|
|
Age, Continuous
|
10 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPercentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
Outcome measures
| Measure |
Dasatinib+Everolimus
n=3 Participants
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.
|
|---|---|
|
Progression-free Survival in Participants With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 12 monthsPercentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
Outcome measures
| Measure |
Dasatinib+Everolimus
n=3 Participants
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.
|
|---|---|
|
Progression-free Survival in Participants With Newly Diagnosed High-grade Glioma (HGG)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 56 DaysThe 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 brain stem for brain stem lesions. Reported as percentage of participants with partial or better response at 56 days.
Outcome measures
| Measure |
Dasatinib+Everolimus
n=3 Participants
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.
|
|---|---|
|
Overall Response Rate (OR) (Partial Response or Better) in Participants With Refractory or Recurrent Glioma
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPercentage of patients alive at one year.
Outcome measures
| Measure |
Dasatinib+Everolimus
n=3 Participants
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.
|
|---|---|
|
Overall Survival
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: up to 17 monthsPercentage of participants alive at 2 years.
Outcome measures
| Measure |
Dasatinib+Everolimus
n=3 Participants
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.
|
|---|---|
|
Overall Survival
|
0 percentage of participants
|
Adverse Events
Dasatinib+Everolimus
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dasatinib+Everolimus
n=3 participants at risk
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.
|
|---|---|
|
Nervous system disorders
headache
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
Other adverse events
| Measure |
Dasatinib+Everolimus
n=3 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Eye disorders
Eye disorders
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Nervous system disorders
Dysarthria
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Nervous system disorders
Ataxia
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Nervous system disorders
Facial nerve disorder
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Gastrointestinal disorders
Vomitting
|
66.7%
2/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
General disorders
Edema face
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Nervous system disorders
tremor
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
33.3%
1/3 • Adverse events were collected up to 30 days after the last dose of study treatment (total of 17 months; average of 4 months). All cause mortality occurred any time during the study (range from 4 - 17 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place