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Janus Kinase (JAK) Inhibitor
Tofacitinib for Glioblastoma
Phase 3
Recruiting
Led By Michael Youssef, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky Performance Status (KPS) ≥ 60%.
GBMs of the study patients must have EGFR gene amplification.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after study treatment
Awards & highlights
Study Summary
This triallooks at if Tofacitinib can help people with recurrent brain cancer live longer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of Tofacitinib may include infections, headaches, diarrhea, high blood pressure and cholesterol levels. More serious risks could involve immune system issues and increased risk of certain cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
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My brain tumor shows increased EGFR gene activity.
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My brain tumor has recurred and is confirmed to be a specific type of aggressive cancer.
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I can swallow pills.
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I agree to use barrier contraception during and for 6 months after treatment.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years after study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) of the study cohort as defined by RANO criteria.
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
Overall survival (OS) of the study cohort.
Tumor response by RANO criteria.
Side effects data
From 2020 Phase 4 trial • 4372 Patients • NCT0209246722%
Upper respiratory tract infection
15%
Bronchitis
13%
Rheumatoid arthritis
13%
Urinary tract infection
12%
Nasopharyngitis
12%
Fall
12%
Herpes zoster
9%
Hypertension
8%
Arthralgia
7%
Diarrhoea
7%
Lymphopenia
7%
Sinusitis
7%
Back pain
6%
Influenza
6%
Osteoarthritis
6%
Latent tuberculosis
6%
Pharyngitis
5%
Nausea
5%
Anaemia
5%
Alanine aminotransferase increased
5%
Cough
4%
Gastroenteritis
3%
Pneumonia
3%
Headache
1%
Coronary artery disease
1%
Femur fracture
1%
Cellulitis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID
TNFi
Trial Design
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.
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,791 Total Patients Enrolled
2 Trials studying Glioblastoma
50 Patients Enrolled for Glioblastoma
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,965 Total Patients Enrolled
25 Trials studying Glioblastoma
935 Patients Enrolled for Glioblastoma
Michael Youssef, MDPrincipal InvestigatorAssistant Professor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to medications similar to Tofacitinib.I can care for myself but may need occasional help.My brain tumor shows increased EGFR gene activity.I have been treated with an EGFR or JAK inhibitor before.I do not have any uncontrolled illnesses.My organs and bone marrow are working well.I have had a severe spike in blood pressure or my high blood pressure is not well-controlled.My brain tumor has recurred and is confirmed to be a specific type of aggressive cancer.I had surgery for a returning tumor and meet healing criteria.I can swallow pills.I am currently being treated with Bevacizumab.My scans show my brain tumor is growing again, 12 weeks after my last radiotherapy.I agree to use barrier contraception during and for 6 months after treatment.I have severe, ongoing nausea or vomiting, trouble swallowing, or have had major gut surgery.I have not taken bevacizumab in the last 180 days.I have recovered from the immediate side effects of my last chemotherapy.I have not had another cancer in the last 3 years, with some exceptions.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Tofacitinib 10 mg
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain the possible risks of Tofacitinib 5 mg to patients?
"Tofacitinib 5 mg is considered safe based on its Phase 3 status. This means that, while there is still some testing to be done in regards to efficacy, the drug has undergone multiple rounds of safety testing."
Answered by AI
Are there any patients needed to participate in this clinical trial?
"That is correct, the study is looking for 20 individuals to participate and is being conducted at 1 location. The clinical trial was first posted on October 7th, 2020, with the most recent update on October 10th, 2020."
Answered by AI
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