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New drug combo targets deadly brain cancer in early trial

NCT ID NCT03535350

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This early-phase study tests whether adding the drug ibrutinib to standard radiation and chemotherapy is safe for people with newly diagnosed glioblastoma, a fast-growing brain cancer. About 36 adults with specific tumor types (MGMT methylated or unmethylated) will receive different dose levels. The main goal is to find the highest safe dose and watch for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Arm 1: * Supratentorial unmethylated MGMT glioblastoma * Gadolinium MRI or contrast CT within 28 days of starting treatment * Karnofsky performance ≥ 70% (http://www.npcrc.org/files/news/karnofsky\_performance\_scale.pdf) * Absolute neutrophil count \> 1500/mm3, platelets \> 100,000/mm3, Creatinine ≤ 1.7 mg/dl, total bilirubin ≤ 1.5mg/dl, transaminases ≤ 3 times above the upper limits of normal * Must be able to provide written informed consent * Patients of reproductive potential must use an acceptable form of birth control to avoid contraception during the period of therapy and up to 90 days after the last dose of study drug. (eg. implants, injectable, oral contraceptives, intrauterine device (IUD), abstinence, and a barrier method which includes, but is not limited to condoms, vaginal rings, and sponges) * Female patients must have a negative pregnancy test upon study entry. * No concurrent malignancy with the exception of curatively treated early stage bladder and prostate cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Any other prior malignancies must be disease free for ≥ 3 years. * Prothrombin time (PT) / international normalized ratio (INR) \< 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT) (aPTT) \< 1.5 x ULN * Patient with any surgery more than stereotactic biopsy are eligible so that there is enough tissue for MGMT analysis. Arm 2: * Arm 1 inclusion criteria must be met with the exception of the histology of the cancer, which must be methylated MGMT glioblastoma Exclusion Criteria: * Serious concurrent infection or illness * Patients who are pregnant or breastfeeding * Patients receiving concurrent therapy for their tumor * Concurrent or prior malignancy unless curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. * Repeat craniotomy for tumor therapy after receiving radiation and TMZ treatment. * Patients who received other chemotherapy or investigational agents in addition to radiation therapy and accompanying TMZ treatment. * Previous ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor use or allergies to components of the study drug. * Use of anticoagulants (including warfarin, other coumadin-derivative anticoagulant, vitamin K antagonists, or low molecular weight heparin) * Use of drugs known to be moderate and strong inhibitor or inducers of the P450 isoenzyme CYP3A. Participants must be off P450/CYP3A inhibitors and inducers for at least a week prior to starting the study drug. * Active, significant liver impairment (Child-Pugh class B or C) * Patient is using systemic immunosuppressant therapy, including cyclosporineA, tacrolimus, sirolimus, and other such medications, or chronic administration of \> 5 mg/day or prednisone or the equivalent.Participants must be off of immunosuppressant therapy for at least 21days prior to the first dose of the study drug. Patients can be on steroids for brain edema. * Significant EKG abnormalities and active and significant cardiovascular disease within 6 months of screening. * Pregnant or breastfeeding women. Male patients that intend to father a child while enrolled or 90 days after the last dose of the study drug. * Unwillingness to comply with the protocol * Uncontrolled, active systemic infection. * Major surgery within 4 weeks of first dose of study drug. * Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug. * Recent infection requiring systemic treatment that was completed ≤ 14 days before the first dose of study drug. * Known bleeding disorders

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.