Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05413304 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 267 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Enrollment increased: 1 → 5 participants · Results posted: Oct 6, 2026 · Interventions modified · 3 more Show 6 more changesShow less
    • Enrollment increased: 1 → 5 participants
    • Results posted: Oct 6, 2026
    • Interventions modified
    • Trial arms changed: 1 → 2
    • Eligibility criteria expanded, about 37 words
    • Study description expanded, about 32 words
  2. Re-verified, no change to tracked fieldsv266
  3. Enrollment target: estimated 17 to confirmed 1 Trial status: Recruiting to Active, Not Recruiting · Primary completion date changed from estimate of Jan 1, 2027 to Oct 21, 2025v265 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jan 1, 2027 to Oct 21, 2025
  4. 4 versions Re-verified since Feb 4, 2026, no change to tracked fieldsv261-v264
  5. Primary completion date: Dec 31, 2025 to Jan 1, 2027 Completion date: Aug 31, 2026 to Sep 1, 2027v260 Show 1 more changeShow less
    • Completion date: Aug 31, 2026 to Sep 1, 2027
Show 42 earlier versionsHide 42 earlier versions
  1. 31 versions Re-verified since Dec 18, 2024, no change to tracked fieldsv229-v259
  2. Enrollment target: 7 to 17 Study description revisedv228 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  3. Study Status, Study Description, Eligibilityv227
  4. 9 versions Re-verified since Aug 1, 2024, no change to tracked fieldsv218-v226
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Diffuse midline gliomas are the most aggressive brain tumors of childhood and young adults. Most people with these tumors survive less than 2 years. Researchers want to see if an anticancer drug (abemaciclib) can help. Objective: To see if researchers can measure how much abemaciclib is in a person's brain tumor and brain fluid after they take the drug for a few days. Eligibility: People aged 18 to 39 with recurrent high-grade glioma or diffuse midline glioma. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Tests of heart function Imaging scans of the brain, with a contrast agent Screening tests will be repeated during the study. Participants will also have chest X-rays. Participants will take abemaciclib by mouth twice a day for 4 and a half days. Participants will undergo surgery. They will have either a tumor biopsy (a needle will be inserted to remove a small piece of tissue) or a surgical resection (part or all of the tumor will be removed). A small tube (catheter) will be placed in their brain for 48 hours to collect fluid samples. They will have a neurological exam every few hours while the tube is in place. Two days later, the tube will be removed without surgery. Participants will stay in the hospital for about 4 days for treatment. Based on the results of abemaciclib levels in the brain, participants may keep taking abemaciclib and another drug (temozolomide) by mouth until their cancer gets worse or they have bad side effects. While taking these two drugs, participants will come back to the clinic for follow-up routinely. They will be followed by the study for life....
Trial Details
NCT Number NCT05413304
Lead Sponsor National Cancer Institute (NCI)
Conditions Glioma
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov