Trial · NCT03782415
Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma
NCT03782415, Phase 1, Phase 2, Completed, MediciNova
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma. Trials, record NCT03782415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03782415
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma
- NCT number
- NCT03782415
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- MediciNova
- Conditions
- Glioblastoma, Recurrent Glioblastoma, GBM, Newly Diagnosed Glioblastoma
- Interventions
- MN-166, Temozolomide
- First posted
- 2018-12-20
- Last updated
- 2025-05-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate safety and tolerability of ibudilast and temozolomide combination treatment | 1-6 months | Determine the proportion of patients with * Treatment-emergent adverse events (TEAEs) as measured by the CTCAE v4.0 and * Treatment discontinuations due to TEAEs and Dose-Limiting Toxicities (DLTs). |
| Primary | Evaluate efficacy of ibudilast and TMZ combination treatment | 1-6 months | Proportion of patients who are progression free at 6 months (PFS6) using the RANO criteria. |
| Secondary | Evaluate Tmax | 1-6 months | Time from start of dosing at which the maximum concentration is observed) |
| Secondary | Cmax | 1-6 months | Maximum observed concentration) |
| Secondary | AUC | 1-6 months | Area under the concentration versus time curve from the start of dose administration to the last quantifiable point within the dosing interval. |
| Secondary | Terminal rate constant | 1-6 months | Calculated from the terminal slope of the log-linear regression of concentration with time. |
| Secondary | Terminal half-life | 1-6 months | Time required for the plasma concentration of a drug to decrease 50% in the final stage of its elimination |
| Secondary | Maximum tolerated dose determination | 1-6 months | Determine maximum tolerable dose of ibudilast taken in combination with TMZ |
| Secondary | Evaluate the safety of fixed-dose ibudilast in combination with TMZ | 1-6 months | Reporting of treatment-emergent adverse events * Treatment-emergent adverse events (TEAEs) as measured by the CTCAE v4.0 and * Treatment discontinuations due to TEAEs and Dose-Limiting Toxicities (DLTs). |
| Secondary | Evaluate overall survival, response rate, and median 6-month progression-free survival (PFS6) | 1-6 months | Overall survival will be measured for each subject with time origin at the date of Study Day 1 until recorded date or death or last follow-up visit. |
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.
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT03782415
GET https://conductscience.org/api/trials/v1/NCT03782415/registered