Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors (NCT02644460) | Clinical Trial Compass
CompletedPhase 1
Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors
United States53 participantsStarted 2016-02
Plain-language summary
This is a Phase I clinical trial evaluating abemaciclib (LY2835219), an inhibitor of cyclin dependent-kinases 4 and 6 (Cdk 4/6) in children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) and in relapsed/refractory/progressive malignant brain (Grade III/IV, including DIPG; MBT) and solid tumor (ST) patients (Stratum B).
Who can participate
Age range
2 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for All Participants:
* Patient must have measurable or evaluable disease.
* Age must be ≥ 2 years and \< 25 years
* Body surface area (BSA) ≥ 0.5 m\^2
* Lansky (for participants ≤ 16 years) or Karnofsky (for participants \> 16 years) performance score ≥ 40 at the time of study enrollment
* Adequate organ function at the time of study enrollment as follows:
* Bone marrow: Absolute neutrophil count (ANC) ≥ 1,000/μL, platelet count ≥ 75,000/μL (transfusion independent for ≥ 7 days), hemoglobin concentration ≥ 8g/dL (may be transfused)
* Patients with bone marrow metastatic disease who do not meet the above criteria will be eligible to enroll in the study with the following count criteria. These patients will not be evaluable for hematologic toxicity or hematologic DLT.
* ANC \> 750/μL within 7 days prior to first dose of abemaciclib
* Platelet count \> 50,000/μL (may receive platelet transfusions) within 7 days prior to first dose of abemaciclib
* Hemoglobin ≥ 7.5 g/dL (may receive red blood cell (RBC) transfusions) within 7 days prior to first dose of abemaciclib
* Renal: Normal serum creatinine concentration based on age or glomerular filtration rate (GFR) \> 70 ml/min/1.73m\^2
* Hepatic: Total bilirubin concentration \< 1.5x the institutional upper limit of normal for age; serum glutamic pyruvic transaminase (SGPT) \< 10x the institutional upper limit of normal for patients on Stratum A. Stratum B patients must have SGPT \< 4x the in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Abemaciclib Maximum Tolerated Dose (MTD) for Diffuse Intrinsic Pontine Glioma (DIPG)
Timeframe: Week 6
2
Abemaciclib Maximum Tolerated Dose (MTD) for Recurrent/Refractory Solid Tumors
Timeframe: Week 6
3
Pharmacokinetics (PK): Predose Concentration (Cmin) of Abemaciclib
Timeframe: Cycle 1 to End of Study (up to two years)
4
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib
Timeframe: Cycle 1 to End of Study (up to two years)
5
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib
Timeframe: Cycle 1 to End of Study (up to two years)