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Janus Kinase (JAK) Inhibitor

Tofacitinib for Treatment-Resistant Colitis

Phase 2
Recruiting
Led By Khashayar Esfahani, MD
Research Sponsored by Khashayar Esfahani
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male condom without spermicide
Cervical cap with spermicide
Must not have
Patients having other concomitant uncontrolled irAEs at the time of enrollment which would require systemic corticosteroids or biologic immunomodulatory agents.
Patients on intravenous biologic agents for other baseline autoimmune conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to 30 days post last dose
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing tofacitinib, an anti-inflammatory drug, in cancer patients who have colitis due to their cancer treatment. The drug aims to reduce inflammation in the colon by blocking specific enzymes, potentially alleviating symptoms like diarrhea. Tofacitinib has been effective in treating ulcerative colitis by reducing inflammation.

Who is the study for?
Adult cancer patients with immune-related colitis from checkpoint inhibitor therapy, who have not responded to corticosteroids and a biologic agent. They must have adequate organ function, no severe liver impairment, and agree to use contraception if of childbearing potential. Excluded are those with recent thromboembolic events, certain infections or uncontrolled autoimmune conditions, pregnancy or breastfeeding women, and prior JAK inhibitor treatment.
What is being tested?
The TRICK Study is testing the effectiveness and safety of Tofacitinib (10 mg) for treating refractory immune-related colitis in cancer patients who previously underwent immune checkpoint inhibitor therapy but did not respond well to standard treatments.
What are the potential side effects?
Tofacitinib may cause side effects such as increased risk of infections due to its impact on the immune system, potential liver enzyme elevations indicating liver injury, changes in blood cell counts which can affect overall health status, and possibly an increased risk of developing blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use male condoms without spermicide.
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I use a cervical cap with spermicide for contraception.
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I've tried steroids and a biologic for my severe diarrhea without success.
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I have severe diarrhea due to immune-related colitis.
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I use a female condom for contraception (not with a male condom).
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I use male condoms with spermicide for contraception.
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I am 18 years old or older.
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My kidneys work well enough, with a clearance rate of 40 mL/min or more.
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I have a solid tumor treated with immune therapy, not including colorectal cancer.
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My liver functions well enough for me to join the study.
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My only partner has had a vasectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have other uncontrolled side effects needing steroids or biologic treatments.
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I am receiving IV treatments for an autoimmune condition.
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I am not allergic to tofacitinib or any drugs used in this study.
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I do not have a severe infection currently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to 30 days post last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to 30 days post last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Remission of Diarrhea
Secondary study objectives
Endoscopic remission
Safety of tofacitinib
Time to clinical remission
+1 more

Side effects data

From 2015 Phase 2 trial • 208 Patients • NCT01786668
8%
Upper respiratory tract infection
8%
Nasopharyngitis
6%
Abdominal pain upper
6%
Vulvovaginal mycotic infection
4%
Mouth ulceration
4%
Headache
4%
Diarrhoea
3%
Balanoposthitis
2%
Rash
2%
Arthralgia
2%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 2 mg BID
Placebo BID
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Tofacitinib 10 mg PO BID for 30 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib 10 mg
2013
Completed Phase 3
~500

Find a Location

Who is running the clinical trial?

Khashayar EsfahaniLead Sponsor
Khashayar Esfahani, MDPrincipal InvestigatorJewish General Hospital

Media Library

Colitis Research Study Groups: Treatment Arm
~1 spots leftby May 2025
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