Trial · NCT01480050
Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma
NCT01480050, Phase 1, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma. Trials, record NCT01480050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01480050
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma
- NCT number
- NCT01480050
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- temozolomide, 3'-deoxy-3'-[18F]fluorothymidine, pharmacological study, Mibefradil
- First posted
- 2011-11-28
- Last updated
- 2019-05-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum-tolerated dose of mibefradil dihydrochloride | 2 years | 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. |
| Primary | Dose-limiting toxicity | 2 years | |
| Secondary | Toxicity and adverse events according to CTCAE v. 4.0 | 2 years | Assess the severity and frequency of adverse events for tested mibefradil dose levels including cumulative toxicity and/or tolerance to adverse effects. |
| Secondary | Biological activity of treatment determined by radiographic response | 3 years | Estimate the number and type of radiographic responses to treatment with mibefradil and temozolomide. |
| Secondary | Pharmacokinetics of mibefradil dihydrochloride as measured by the steady-state maximum plasma concentration (Cmax) | Day 8 | Cmax (ng/mL) of mibefradil dihydrochloride at steady-state in plasma. |
| Secondary | Potential effect of mibefradil dihydrochloride on tumor metabolism as determined by [F-18]FLT PET scans in the dose-expansion cohort | 6 months | Assess the potential effect of mibefradil on tumor metabolism as determined by fluorothymidine positron emission tomography-computed tomography (FLT PETCT) scans with the radiotracer \[18F\]-3'-fluoro-3'-deoxy-L-thymidine. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28371832 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01480050
GET https://conductscience.org/api/trials/v1/NCT01480050/registered