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NCT01480050 · ClinicalTrials.gov registry record · Phase 1
Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01480050: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01480050 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01480050, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
RATIONALE: Mibefradil dihydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the best dose of mibefradil dihydrochloride when given together with temozolomide in treating patients with glioma.
Primary Outcome
Determine the maximum tolerated dose (MTD) of mibefradil administered prior to five days of temozolomide (TMZ) at 150-200 mg/m2 in subjects with progressive or recurrent high grade glioma.
Interventions
- DRUG temozolomide
- OTHER pharmacological study
- OTHER 3'-deoxy-3'-[18F]fluorothymidine
- DRUG Mibefradil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-05-31 |
| Est. Completion | 2017-06-01 |
| Phase | Phase 1 |
What the finished NCT01480050 record still lists
NCT01480050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which temozolomide is the first listed.
NCT01480050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01480050 about?
NCT01480050 is a clinical study titled "Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma". RATIONALE: Mibefradil dihydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. ...
What is the current status of trial NCT01480050?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2012-05-31. Estimated completion is 2017-06-01.
What interventions are being tested in trial NCT01480050?
The interventions under investigation include: temozolomide (DRUG), pharmacological study (OTHER), 3'-deoxy-3'-[18F]fluorothymidine (OTHER), Mibefradil (DRUG).
Who is sponsoring clinical trial NCT01480050?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01480050's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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