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

Sponsor: Khashayar Esfahani
Study ID: NCT04768504
Phase: PHASE2
Status: Terminated

Conditions

Immune-Mediated Colitis

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Tofacitinib 10 mg — DRUG
Tofacitinib 10 mg PO BID for 30 days

Study Details

This is a single-arm pilot study evaluating the efficacy and safety of tofacitinib in cancer patients with immune-related colitis from immune checkpoint inhibitor (ICI) therapy.

Key Dates

Start date: Mar 22, 2022
Status verified: Nov 2024
Primary completion: Jan 17, 2024
Completion: Jan 17, 2024

Study Design

Enrollment: 2 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Treatment Arm
Tofacitinib 10 mg PO BID for 30 days

Primary Outcome Measure

Clinical Remission of Diarrhea [ Time Frame: 8 weeks from first dose ]