A Phase 2 interventional study of Dasatinib and Everolimus in Glioma, High Grade Glioma and Pontine Tumors, sponsored by University of Michigan Rogel Cancer Center. Terminated at 1 site in United States. Open to participants aged 1 Year to 50 Years. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment
Among 10 studies testing everolimus in Glioma — 2 open to participants now, 2 under way, none of them phase 3. Everolimus · Glioma.
Among the 10 studies testing everolimus in Glioma, this one is the 9th largest by enrollment, is one of 2 that started in 2017, is one of 6 in phase 2, and was the 4th registered.
1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.
This study's enrollment of 3 is below the median of 32 across 1,075 interventional studies indexed under Glioma.
Browse Glioma studies →2 of the 10 studies testing everolimus in Glioma are open now, in 6 countries. Each count lists the studies.
Everolimus: first FDA approval 2009 (AFINITOR), first EMA approval 2009. What it is approved for, and how studies give it, is on its page →
Of the 267 Glioma studies recruiting now, 164 (61%) set no upper age limit and 57 (21%) stop at 75 or younger; 63 take children under 18; 15 take healthy volunteers.
This study: 1 Year to 50 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2017.
Median enrollment 23 across the 10 interventional studies. Of the 7 that completed or were terminated, 6 (86%) have results posted.
None of the 10 has an industry lead sponsor. The 9 most frequent:
University of Michigan Rogel Cancer Center is the lead sponsor of 323 studies on the registry; 47 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
University of Michigan Rogel Cancer Center has 5 studies filed under Glioma — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing everolimus in Glioma, from their registry updates:
Nothing recorded among them since 2026-09-25.
This trial will evaluate the activity of dasatinib in combination with everolimus for children with gliomas harboring PDGFR alterations, including newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) after radiation (stratum A); and recurrent/progressive glioma (grade II-IV, including DIPG) (stratum B).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Radiation therapy:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dasatinib · Drug: Everolimus
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)
Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
Time frame: 8 months
Progression-free Survival in Participants With Newly Diagnosed High-grade Glioma (HGG)
Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
Time frame: 12 months
Overall Response Rate (OR) (Partial Response or Better) in Participants With Refractory or Recurrent Glioma
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 brain stem for brain stem lesions. Reported as percentage of participants with partial or better response at 56 days.
Time frame: 56 Days
Overall Survival
Percentage of patients alive at one year.
Time frame: 1 year
Overall Survival
Percentage of participants alive at 2 years.
Time frame: up to 17 months
| Milestone | Dasatinib+Everolimus |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
| percentage of participants | Dasatinib+Everolimus |
|---|---|
| Progression-free Survival in Participants With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) | 0 |
Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.
| percentage of participants | Dasatinib+Everolimus |
|---|---|
| Progression-free Survival in Participants With Newly Diagnosed High-grade Glioma (HGG) | 0 |
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 brain stem for brain stem lesions. Reported as percentage of participants with partial or better response at 56 days.
| percentage of participants | Dasatinib+Everolimus |
|---|---|
| Overall Response Rate (OR) (Partial Response or Better) in Participants With Refractory or Recurrent Glioma | 0 |
Percentage of patients alive at one year.
| percentage of participants | Dasatinib+Everolimus |
|---|---|
| Overall Survival | 0 |
Percentage of participants alive at 2 years.
| percentage of participants | Dasatinib+Everolimus |
|---|---|
| Overall Survival | 0 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dasatinib+Everolimus | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Dasatinib+Everolimus |
|---|---|
| headacheNervous system disorders | 1/3 |
| Event | Dasatinib+Everolimus |
|---|---|
| DiarrheaGastrointestinal disorders | 3/3 |
| MyalgiaMusculoskeletal and connective tissue disorders | 2/3 |
| VomittingGastrointestinal disorders | 2/3 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 2/3 |
| HeadacheNervous system disorders | 2/3 |
| Muscle weakness lower limbMusculoskeletal and connective tissue disorders | 1/3 |
| Eye disordersEye disorders | 1/3 |
| DysarthriaNervous system disorders | 1/3 |
| FatigueGeneral disorders | 1/3 |
| AtaxiaNervous system disorders | 1/3 |
| Age, Continuous(years) | Dasatinib+Everolimus |
|---|---|
| Mean | 10 (4 to 18) |
| Sex: Female, Male(Participants) | Dasatinib+Everolimus |
|---|---|
| Female | 2 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Dasatinib+Everolimus |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Dasatinib+Everolimus |
|---|---|
| United States | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Apr 2019, 16 months.
Results were first posted in Oct 2022, 3 years 5 months after primary completion. A results delay was requested in Oct 2021.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dasatinib · Everolimus
University of Michigan Rogel Cancer Center →