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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 moreTrial 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)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cachexia treatments often target the underlying mechanisms of inflammation and appetite regulation. Appetite stimulants like ghrelin mimetics (e.g., anamorelin) increase food intake and lean body mass.
Inhibitors of the JAK/STAT pathway, such as Ruxolitinib, reduce inflammation and muscle degradation by blocking the inflammatory response that contributes to cachexia. These treatments are crucial as they address the multifaceted nature of cachexia, aiming to improve patient quality of life and overall outcomes.
Sex and Gender Differences in Anticancer Treatment Toxicity: A Call for Revisiting Drug Dosing in Oncology.Do body composition parameters correlate with response to targeted therapy in ER+/HER2- metastatic breast cancer patients? Role of sarcopenia and obesity.Systematic review of the treatment of cancer-associated anorexia and weight loss.
Sex and Gender Differences in Anticancer Treatment Toxicity: A Call for Revisiting Drug Dosing in Oncology.Do body composition parameters correlate with response to targeted therapy in ER+/HER2- metastatic breast cancer patients? Role of sarcopenia and obesity.Systematic review of the treatment of cancer-associated anorexia and weight loss.
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Who is running the clinical trial?
Tu DanLead Sponsor
Puneeth IyengarLead Sponsor
Incyte CorporationIndustry Sponsor
368 Previous Clinical Trials
55,451 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking part in another clinical trial for treating lung or other cancers.You have tumors with specific mutations that can be treated with targeted drugs.You do not have signs of severe weight loss and muscle weakness caused by cancer.You have another type of cancer that needs treatment at the same time, except for hormonal therapy, and it might affect how long you will live.You have been diagnosed with non-small cell lung cancer, confirmed by a biopsy or tissue sample.You have been treated with a JAK inhibitor before.You have had serious heart or blood vessel problems within the last 3 months.You are expected to live for at least 6 more months.You have not received any treatment before for advanced lung cancer.You have received treatment before for advanced lung cancer.You've had allergic reactions to drugs like ruxolitinib or other similar medications.Your liver or kidney function is not within the acceptable ranges.You have advanced stage lung cancer that has been confirmed by specific tests, and the cancer can be measured according to certain guidelines.Your organs are working well, according to standard medical tests and guidelines.You have a severe infection that needs to be treated.You have not fully recovered from side effects of previous treatments, as determined by your doctor.You have non-small cell lung cancer that is in stage I, II, or III.You are able to perform daily activities without any major limitations.You are taking medication that could suddenly worsen your health.You are expected to live for less than 6 months.You are taking strong CYP3A4 inhibitors or fluconazole.You have signs of severe weight loss and muscle weakness due to cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Dosing Regimen for Ruxolitinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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