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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

Must not have

Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease

History of Grade 2 (CTCAE v4.0) or greater intracranial or intratumoral hemorrhage confirmed by either MRI or CT scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious health conditions like heart, kidney, or liver diseases.

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I have had a serious brain bleed confirmed by a scan.

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I am not on coumadin but may be using other blood thinners.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate efficacy of ibudilast and TMZ combination treatment

Evaluate safety and tolerability of ibudilast and temozolomide combination treatment

Secondary study objectives

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

intestinal obstruction

pneumonia

Lower limb fracture

Hydronephrosis

Ureterolithiasis

Deep vein thrombosis

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1880