17 Participants Needed

Tofacitinib for Glioblastoma

OR
Overseen ByOmar Raslan, MBBCH,MPH,CCRP
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on Bevacizumab or any investigational agents for the cancer under study. If you have been on Bevacizumab, you must stop it for 180 days before joining the trial.

Is Tofacitinib generally safe for humans?

Tofacitinib, used for conditions like psoriatic arthritis and rheumatoid arthritis, has shown an acceptable safety profile in clinical trials, with low rates of serious infections, cancer, heart issues, and gut problems. Common side effects include infections and changes in blood tests, but it is generally well-tolerated in humans.12345

How is the drug Tofacitinib different from other treatments for glioblastoma?

Tofacitinib is unique because it is a Janus kinase (JAK) inhibitor, which is a different mechanism of action compared to the standard treatments for glioblastoma like Temozolomide, which is a DNA-methylating agent, and bevacizumab, which targets vascular endothelial growth factor (VEGF). This novel approach may offer a new pathway for treating glioblastoma.678910

What is the purpose of this trial?

This trial tests Tofacitinib, an oral medication, on patients with recurrent Glioblastoma. The drug works by reducing immune system activity, potentially slowing or stopping cancer growth. Tofacitinib is an oral medication initially used for the treatment of rheumatoid arthritis.

Research Team

MY

Michael Youssef, MD

Principal Investigator

Assistant Professor

Eligibility Criteria

Adults with recurrent Glioblastoma (GBM) who've had prior treatment, can swallow pills, and have a Karnofsky Performance Status of at least 60%. They must use contraception if of childbearing potential. Excluded are those with uncontrolled hypertension, other recent cancers, certain allergies or conditions that affect drug absorption or compliance.

Inclusion Criteria

I can care for myself but may need occasional help.
My brain tumor shows increased EGFR gene activity.
Patients must be willing and able to provide written informed consent and to comply with the study protocol as judged by the investigator.
See 9 more

Exclusion Criteria

I am allergic to medications similar to Tofacitinib.
Subjects must not be pregnant or nursing.
Patients unable to undergo brain MRI scans with IV gadolinium contrast.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tofacitinib 10 mg twice daily in 28-day cycles with assessments on Day 1 of each cycle

28 days per cycle
1 visit per cycle (in-person)

Interim Follow-up

Interim follow-up after the second cycle includes brain MRI for tumor measurements and other assessments

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including brain MRI and toxicity evaluations every 4 weeks

Up to 2 years

Treatment Details

Interventions

  • Tofacitinib
Trial Overview The trial is testing the effects of Tofacitinib 10mg on patients with recurrent GBM. It aims to see how well this medication works for those whose tumors have EGFR gene amplification and who meet specific health criteria.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Tofacitinib 10 mgExperimental Treatment1 Intervention
Participants will take the 10mg Tofacitinib twice daily until evidence of progression, intolerance of treatment, withdrawal of consent, or death.

Tofacitinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Xeljanz for:
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Ulcerative Colitis
  • Ankylosing Spondylitis
  • Polyarticular Course Juvenile Idiopathic Arthritis
🇪🇺
Approved in European Union as Xeljanz for:
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Ulcerative Colitis
  • Ankylosing Spondylitis

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Tofacitinib (5 mg twice daily) significantly improves key symptoms of active psoriatic arthritis (PsA) and related conditions after 3 months of treatment, with benefits maintained for up to 30 months in ongoing studies.
The drug has an acceptable safety profile, showing low rates of serious infections, malignancies, and other adverse events over 36 months, indicating it is a viable option for patients who have not responded to previous therapies.
Tofacitinib: A Review in Psoriatic Arthritis.Paik, J., Deeks, ED.[2020]
Tofacitinib, an oral JAK inhibitor, demonstrated bioequivalence to Xeljanz® in a phase I trial involving 32 healthy Chinese subjects, with pharmacokinetic parameters such as peak concentration and area under the curve falling within the acceptable range of 80-125%.
The safety profile of tofacitinib was found to be comparable to that of Xeljanz®, supporting its potential for clinical use in treating inflammatory and autoimmune diseases.
A randomized, crossover, phase I clinical study to evaluate bioequivalence and safety of tofacitinib and Xeljanz® in Chinese healthy subjects.Xu, Z., Wang, Y., Liu, Z., et al.[2022]
Tofacitinib aspartate (7.13 mg) demonstrated bioequivalence to the reference formulation tofacitinib citrate (8.08 mg) in a study involving 41 healthy volunteers, indicating similar pharmacokinetic profiles for both formulations.
The study found that both formulations were well-tolerated, with no significant differences in maximum concentration (Cmax) and area under the concentration-time curve (AUClast), suggesting that tofacitinib aspartate can be a viable alternative to the existing formulation.
Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects.Shin, W., Yang, AY., Yun, H., et al.[2022]

References

Tofacitinib: A Review in Psoriatic Arthritis. [2020]
A randomized, crossover, phase I clinical study to evaluate bioequivalence and safety of tofacitinib and Xeljanz® in Chinese healthy subjects. [2022]
Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects. [2022]
Tofacitinib in the treatment of active rheumatoid arthritis in adults. [2018]
[A new therapeutical option for chronic inflammation in rheumatology: janus kinases inhibitors (JAK)]. [2014]
Targeting integrins in malignant glioma. [2021]
7.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Current and Future Drug Treatments for Glioblastomas. [2019]
Inhibition of elongation factor-2 kinase augments the antitumor activity of Temozolomide against glioma. [2021]
Phase II trial of gefitinib in recurrent glioblastoma. [2022]
Contemporary Updates on Clinical Trials of Antiangiogenic Agents in the Treatment of Glioblastoma Multiforme. [2020]
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