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JAK Inhibitor

Ruxolitinib for Non-Small Cell Lung Cancer Cachexia

Phase < 1
Recruiting
Led By Tu Dan, MD
Research Sponsored by Tu Dan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help treat NSCLC cachexia (wasting away) patients by targeting the JAK/STAT signaling.

Who is the study for?
Adults with advanced Non-Small Cell Lung Cancer and cachexia can join this trial. They must have a life expectancy of at least 6 months, no prior treatment for their lung cancer, and agree to use contraception. Those with certain mutations or other active cancers, previous JAK inhibitor treatments, or serious health issues like heart failure are excluded.Check my eligibility
What is being tested?
The trial is testing the safety of Ruxolitinib in treating cachexia in lung cancer patients. It aims to find any toxic effects from different doses and see how it affects signaling pathways related to muscle and fat tissue before and after treatment.See study design
What are the potential side effects?
Potential side effects include reactions similar to those seen with drugs that affect immune signaling pathways such as changes in blood counts, risk of infections, liver function alterations, and possibly others not yet known due to the investigational nature of the drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of non-small cell lung cancer cachexia patients with toxicity with the use of Ruxolitinib
Secondary outcome measures
Analysis of any preliminary evidence suggesting that Ruxolitinib improves overall survival in cancer cachexia patients.
Analysis of any preliminary evidence suggesting that Ruxolitinib suppresses adipose and lean muscle loss in cancer cachexia patients.
Analysis of any preliminary evidence suggesting that Ruxolitinib suppresses anorexia in cancer cachexia patients.
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dosing Regimen for RuxolitinibExperimental Treatment1 Intervention
Level 0: Ruxolitinib 0 MG po bid for 1 month (Month 1) Level 1: Ruxolitinib 10 MG po bid for 1 month (Month 2) Level 2: Ruxolitinib 15 MG po bid for 1 month (Month 3)

Find a Location

Who is running the clinical trial?

Tu DanLead Sponsor
Puneeth IyengarLead Sponsor
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,155 Total Patients Enrolled

Media Library

Ruxolitinib (JAK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04906746 — Phase < 1
Cachexia Research Study Groups: Dosing Regimen for Ruxolitinib
Cachexia Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT04906746 — Phase < 1
Ruxolitinib (JAK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906746 — Phase < 1

Frequently Asked Questions

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

To what kinds of conditions is ruxolitinib generally applied to assuage symptoms?

"This trial seeks to recognize any dose-limiting toxicity (DLT) that may occur while treating NSCLC cachexia patients using ruxolitinib, a medication commonly used for polycythemia vera. Additionally, this drug has proven effective in relieving symptoms of refractory or hydroxyurea-intolerant primary myelofibrosis."

Answered by AI

What are the stated objectives of this experiment?

"Per the Incyte Corporation, sponsor of this trial, the primary outcome to be measured over a 3-month period is Number of participants with Objective Response (OR), assessed using iRECIST criteria. Secondary outcomes include: Number of adverse events associated with ruxolitinib when administered to cancer cachexia patients via NCI's CTCAE v5.0 toxicity criteria; Analysis providing any initial evidence that ruxolitinib boosts quality of life for cancer cachexia patients by way off EORTC QLQ-CAX24 questionnaire given every two weeks and one month after treatment; and finally, Number of participants with"

Answered by AI

Are new participants being enrolled in this experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this trial was first published on February 23rd 2022 and is currently open for recruitment. The study seeks around 20 volunteers from a single medical centre."

Answered by AI

How many participants is the trial allowing to join?

"Affirmative. According to clinicaltrials.gov, this ongoing medical study is actively seeking enrollees and was initially posted on February 23rd 2022 with the most recent update having been made April 27th 2022. The trial requires 20 patients from a single site for participation."

Answered by AI
~3 spots leftby Apr 2025