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Ibudilast + Temozolomide for Brain Cancer

Phase 1 & 2

Waitlist Available

Led By Patrick Wen, MD

Research Sponsored by MediciNova

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously received standard front-line GBM treatment including maximal surgical resection followed by external beam radiation therapy and TMZ therapy. Prior use of NovoTTF (Optune) and Gliadel wafers is allowed

Histologically confirmed GBM (glioblastoma), WHO Grade 4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-6 months

Awards & highlights

Study Summary

This trial is testing a combination of two drugs, MN-166 and temozolomide, to see if it is safe and effective in treating brain cancer.

Who is the study for?

Adults with confirmed Grade 4 glioblastoma experiencing their first relapse after standard treatment, including surgery and chemotherapy, can join. They should have measurable disease by MRI, be in good physical condition (KPS ≥70 or ECOG 0-2), and not have had more than one prior therapy. Those with certain past cancers or recent anti-cancer treatments are excluded.Check my eligibility

What is being tested?

The trial is testing a combination of Ibudilast (MN-166) and Temozolomide (TMZ) on patients with glioblastoma. Part 1 determines the safe dosage over a cycle of 28 days; Part 2 tests the efficacy for up to six cycles or until progression, unacceptable side effects occur, or loss of life.See study design

What are the potential side effects?

Potential side effects include those related to TMZ such as fatigue, nausea, vomiting, constipation, headache and potential blood disorders like low platelet count. Side effects from MN-166 may include gastrointestinal symptoms and weakness but will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had surgery, radiation, and TMZ therapy for my brain tumor.

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My diagnosis is Grade 4 glioblastoma.

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My condition has worsened for the first time since treatment.

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I am mostly able to carry on with my normal activities.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate efficacy of ibudilast and TMZ combination treatment

Evaluate safety and tolerability of ibudilast and temozolomide combination treatment

Secondary outcome measures

AUC

Cmax

Evaluate Tmax

+5 more

Side effects data

From 2017 Phase 2 trial • 70 Patients • NCT02238626

53%

muscle weakness

41%

Fall

35%

Fatigue

26%

Decreased appetite

21%

nausea

21%

weight decreased

21%

muscle spasms

18%

dyspnea

15%

injury

12%

headache

dysphagia

Ureterolithiasis

pneumonia

intestinal obstruction

Lower limb fracture

Deep vein thrombosis

Hydronephrosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo (for MN-166) (Early ALS Cohort)

MN-166 (Early ALS Cohort)

Placebo (for MN-166) (Advanced ALS Cohort)

MN-166 (Advanced ALS Cohort)

Trial Design

1Treatment groups

Experimental Treatment

Group I: MN-166 and temozolomideExperimental Treatment2 Interventions

Part 1: Combination treatment of MN-166 60 mg/day (30 mg twice a day) for 28 days and temozolomide 150 mg/m² on Days 1-5 of 28-day cycle. Part 2: Open-label, fixed-dose MN-166 and temozolomide combination treatment for 6 cycles until disease progression, unacceptable tolerability and/or toxicity or loss of life.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MN-166

2019

Completed Phase 2

~110

Temozolomide

2010

Completed Phase 3

~1930

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

MediciNovaLead Sponsor

19 Previous Clinical Trials

1,470 Total Patients Enrolled

Patrick Wen, MDPrincipal InvestigatorDana-Farber Cancer Institute

10 Previous Clinical Trials

352 Total Patients Enrolled

6 Trials studying Glioblastoma

231 Patients Enrolled for Glioblastoma

Kazuko Matsuda, MD PhD MPHStudy DirectorMediciNova, Inc.

4 Previous Clinical Trials

329 Total Patients Enrolled

Media Library

MN-166 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03782415 — Phase 1 & 2

Glioblastoma Research Study Groups: MN-166 and temozolomide

Glioblastoma Clinical Trial 2023: MN-166 Highlights & Side Effects. Trial Name: NCT03782415 — Phase 1 & 2

MN-166 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03782415 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main condition that MN-166 has been shown to improve?

"Nitrosourea treatment, advance directives, and refractory, advanced mycosis fungoides can all be treated with the use of MN-166."

Answered by AI

How many individuals are in this experiment?

"This clinical trial is no longer enrolling patients. It was initially posted on December 29th, 2018 but has not been edited since November 16th, 2020. For other studies, there are currently 1445 trials actively recruiting patients with glioblastoma and 223 studies for MN-166 actively looking for participants."

Answered by AI

Are there other ongoing studies involving MN-166?

"At this moment in time, a total of 223 clinical trials are underway that focus on MN-166. Out of those, 27 have progressed to Phase 3 testing. Most of the research taking place for MN-166 is centred in Seoul and Songpa; however, there are 4,852 locations worldwide where some form of trial is running."

Answered by AI

Have similar clinical trials been conducted before?

"Since 2002, MN-166 has been the focus of a number of clinical trials. The first study was sponsored by Schering-Plough and involved 60 people. Based on the promising results of that initial trial, MN-166 received Phase 2 drug approval in 2002. As of now, there are 223 ongoing trials for MN-166 being conducted across 948 cities and 36 countries worldwide."

Answered by AI

Are there any vacant slots in this trial for new participants?

"Presently, this trial is not recruiting patients. The clinical study was initially posted on December 29th, 2018 and last updated on November 16th, 2022. For other options, there are 1445 trials actively looking for patients with glioblastoma and 223 studies for MN-166 enrolling patients right now."

Answered by AI

What is the main purpose of this clinical trial?

"The sponsor of this clinical trial, MediciNova, reports that the main objective is to evaluate the efficacy of a combination treatment with ibudilast and TMZ over a period of 1-6 months. Additionally, this trial will assess secondary outcomes related to Tmax, terminal half-life, overall survival, response rate, and median 6-month progression-free survival (PFS6)."

Answered by AI

Recent research and studies

XenobioticaJournal

Cross-species Comparisons of the Pharmacokinetics of Ibudilast

Sanftner, L. M., J. A. Gibbons, M. I. Gross, B. M. Suzuki, F. C. A. Gaeta, and K. W. Johnson. 2009. “Cross-species Comparisons of the Pharmacokinetics of Ibudilast”. Xenobiotica. Informa UK Limited. doi:10.3109/00498250903254340.

European Journal of PharmacologyJournal

The Inhibitory Profile of Ibudilast Against the Human Phosphodiesterase Enzyme Family

Gibson, Lucien C.D., Stuart F. Hastings, Ian McPhee, Robert A. Clayton, Claire E. Darroch, Alison Mackenzie, Fiona L. MacKenzie, Michiaki Nagasawa, Patricia A. Stevens, and Simon J. MacKenzie. 2006. “The Inhibitory Profile of Ibudilast Against the Human Phosphodiesterase Enzyme Family”. European Journal of Pharmacology. Elsevier BV. doi:10.1016/j.ejphar.2006.02.053.

Proceedings of the National Academy of SciencesJournal

Allosteric Inhibition of Macrophage Migration Inhibitory Factor Revealed by Ibudilast

Cho, Yoonsang, Gregg V. Crichlow, Jon J. Vermeire, Lin Leng, Xin Du, Michael E. Hodsdon, Richard Bucala, et al.. 2010. “Allosteric Inhibition of Macrophage Migration Inhibitory Factor Revealed by Ibudilast”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1002716107.

clinicaltrials.govStudy