NCT05326464

Tofacitinib in Recurrent GBM Patients

Tofacitinib: Suppressing Tumor Invasion in Recurrent GBM Patients

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Tofacitinib 10mg	10 mg given orally twice daily until evidence of progression, intolerance of treatment, withdrawal of consent, or death.

Timeline

• Start date: 2022-10-07
• Primary completion: 2025-06-16
• Completion: 2027-06-01
• First posted: 2022-04-13
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study