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NCT05236036 · ClinicalTrials.gov registry record · Phase 1
Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma
A Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Northwestern University.
- Active
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT05236036: Active Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Northwestern University.
NCT05236036 is a Phase 1 study of Glioblastoma and Recurrent Glioblastoma that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 60 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (45% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05236036, a Phase 1 study of Glioblastoma and Recurrent Glioblastoma, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I/Ib trial tests the safety, side effects, and best dose of mycophenolate mofetil in combination with temozolomide and/or radiation therapy (standard of care) in treating patients with glioblastoma. Mycophenolate mofetil is an immunosuppressant drug that is typically used to prevent organ rejection in transplant recipients. However, mycophenolate mofetil may also help chemotherapy with temozolomide work better by making tumor cells more sensitive to the drug. The purpose of this trial is to determine if mycophenolate mofetil combined with temozolomide can stop glioblastoma.
Primary Outcome
Will be based on treatment-emergent and drug related toxicity of grade \>= 3 during the first cycle of treatment. MTD indicates maximum tolerated dose for dose limiting toxicity (DLT). DLT is defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. Recommended phase 2 dose (RP2D) is the highest dose of a drug or treatment that does not cause unacceptable side effects. For the purposes of this study, RP2D is interchang
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DRUG Mycophenolate Mofetil
Study Locations (3)
Illinois
- Northwestern University - Chicago
- Northwestern Lake Forest Hospital - Lake Forest
- Northwestern Medicine Warrenville - Warrenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-08-08 |
| Est. Completion | 2029-01-03 |
| Phase | Phase 1 |
What the registry record for NCT05236036 still lists
NCT05236036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (45% lower).
The record links to 5 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05236036 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05236036 about?
NCT05236036 is a clinical study titled "Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma". This phase I/Ib trial tests the safety, side effects, and best dose of mycophenolate mofetil in combination with temozolomide and/or radiation therapy (standard of care) in treating patients with glioblastoma. Mycophenolate mofetil is an immunosuppressant drug that is typically used to prevent organ...
What is the current status of trial NCT05236036?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-08-08. Estimated completion is 2029-01-03.
What conditions does trial NCT05236036 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma, Astrocytoma, Glioblastoma, IDH-wildtype, MGMT-Unmethylated Glioblastoma.
What interventions are being tested in trial NCT05236036?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Radiation Therapy (RADIATION), Temozolomide (DRUG), Mycophenolate Mofetil (DRUG).
Who is sponsoring clinical trial NCT05236036?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05236036 being conducted?
This trial has 3 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05236036's enrollment target sits among peer trials
60 75th of 199 higher than 122 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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