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Tofacitinib in Recurrent GBM Patients | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Tofacitinib in Recurrent GBM Patients

Tofacitinib: Suppressing Tumor Invasion in Recurrent GBM Patients

NCT05326464•University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to examine the effects of Tofacitinib in patients with recurrent Glioblastoma.

Detailed Description

Once consented and registered, eligible patients will commence Cycle 1 and be assessed on Cycle 1 Day 1. An entire cycle will be 28 days of continuous Tofacitinib dosing. There will be a gap of 18-24 days between the first and subsequent cycles of treatment. The patient will once again be assessed on Cycle 2 Day 1. An interim follow-up will be done after the second cycle, during which the patient will undergo a brain MRI for tumor measurements along with all other assessments. Subsequent cycles will continue as prior, with subject assessments, brain MRI, and toxicity evaluations every 4 weeks. Treatments will stop upon evidence of disease progression, unacceptable toxicity, or if the physician deems it unsafe for the subject to continue in the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•2. Imaging confirmation of first tumor progression or regrowth as defined by the Response Assessment in Neuro-Oncology (RANO) criteria. A minimum of 12 weeks must have elapsed from the completion of radiotherapy to study entry to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling.
•3. Karnofsky Performance Status (KPS) ≥ 60%.
•4. Patients must be willing and able to provide written informed consent and to comply with the study protocol as judged by the investigator.
•5. Age ≥ 18 years.
•6. Patients must be able to swallow oral medications.
•7. For women who are of child-bearing potential and who are sexually active and who are not surgically sterile (absence of ovaries and/or uterus): to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the treatment period and for at least 6 months after last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. For male patients who are partners of premenopausal women: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of study drug.
•7.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
•* Has not undergone a hysterectomy or bilateral oophorectomy; or
•* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
•8. Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
+14 more criteria

Exclusion Criteria

•1. Prior treatment with an EGFR or JAK inhibitor.
•2. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
•3. Patients unable to undergo brain MRI scans with IV gadolinium contrast.
•4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Tofacitinib
•5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
•6. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
•7. Prior history of hypertensive crisis, hypertensive encephalopathy, or inadequately controlled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg while on antihypertensive medication).
•8. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant gastrointestinal resection that would preclude adequate absorption of the trial medications.
•9. History of another malignancy in the previous 3 years, with a disease-free interval of \< 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
•10. Concurrent use of Bevacizumab.

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

October 7, 2022

Primary Completion Date

June 16, 2025

Completion Date

June 1, 2027

Last Updated

December 15, 2025

Enrollment

ACTUAL participants

Conditions

Glioblastoma

Interventions

Tofacitinib 10mg

DRUG

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

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Glioblastoma Multiforme

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Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tofacitinib in Recurrent GBM Patients

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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