← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose to 30 days post last dose

Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with cancer who have colitis from other cancer treatments.

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.Check my eligibility

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.See study design

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

Select...

I use male condoms without spermicide.

Select...

I use a cervical cap with spermicide for contraception.

Select...

I've tried steroids and a biologic for my severe diarrhea without success.

Select...

I have severe diarrhea due to immune-related colitis.

Select...

I use a female condom for contraception (not with a male condom).

Select...

I use male condoms with spermicide for contraception.

Select...

I am 18 years old or older.

Select...

My kidneys work well enough, with a clearance rate of 40 mL/min or more.

Select...

I have a solid tumor treated with immune therapy, not including colorectal cancer.

Select...

My liver functions well enough for me to join the study.

Select...

My only partner has had a vasectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose to 30 days post last dose

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Remission of Diarrhea

Secondary outcome measures

Endoscopic remission

Safety of tofacitinib

Time to clinical remission

+1 more

Side effects data

From 2015 Phase 2 trial • 208 Patients • NCT01786668

Upper respiratory tract infection

Nasopharyngitis

Abdominal pain upper

Vulvovaginal mycotic infection

Mouth ulceration

Headache

Diarrhoea

Balanoposthitis

Rash

Arthralgia

Alanine aminotransferase increased

100%

80%

60%

40%

20%

Study treatment Arm

Placebo BID

Tofacitinib 2 mg BID

Tofacitinib 5 mg BID

Tofacitinib 10 mg BID

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

0 / 11Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration sanctioned Tofacitinib 10 mg as a therapeutic option?

"In our assessment, Tofacitinib 10 mg is likely safe due to the Phase 2 trial results which suggest safety but no efficacy. We gave it a score of 2 out of 3."

Answered by AI

What illnesses is Tofacitinib 10 mg typically prescribed for?

"Tofacitinib 10 mg is often prescribed to patients with juvenile arthritis, and can also be beneficial for those that have an intolerance of methotrexate or are not responding adequately to the conventional treatment plan."

Answered by AI

Could you please outline any other research projects utilizing Tofacitinib 10 mg?

"Currently, 34 clinical trials are underway for Tofacitinib 10 mg with 7 of them in the concluding phase 3. Most of these experiments originate from Shanghai yet there is a global reach of 662 locations trialing it."

Answered by AI

Has recruitment for this clinical trial resumed?

"Clinicaltrials.gov confirms that the recruitment process for this clinical trial began on March 22nd 2022 and has been refreshed as of October 12th 2022, indicating it is still in need of participants."

Answered by AI

What is the current participant capacity for this trial?

"Affirmative. Clinicaltrials.gov data verifies that this medical trial, which was first published on March 22nd 2022, is actively searching for suitable participants. Approximately 10 individuals are being sought from 1 specified site."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Tofacitinib for Refractory Immune-related Colitis from PD-1 Therapy

Esfahani, Khashayar, Marie Hudson, and Gerald Batist. 2020. “Tofacitinib for Refractory Immune-related Colitis from PD-1 Therapy”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmc2002527.

clinicaltrials.govStudy

Tofacitinib for the Treatment of Refractory Immune-related Colitis From Checkpoint Inhibitor Therapy- TRICK Study

Khashayar Esfahani 2022. "Tofacitinib for the Treatment of Refractory Immune-related Colitis From Checkpoint Inhibitor Therapy- TRICK Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04768504.

All > Xeljanz > Colitis