Active — Not RecruitingEarly Phase 1

Ruxolitinib for Cancer Cachexia

United States10 participantsStarted 2022-02-23

Plain-language summary

To assess toxicity with use of Ruxolitinib in NSCLC cachexia patients; to associate levels of JAK/STAT signaling in blood, adipose, and muscle pre- and post-ruxolitinib treatment with changes in cachexia and anorexia.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female subjects at least 18 years of age;
✓. Ability to understand and the willingness to sign a written informed consent;
✓. Histological or biopsy proven Non-Small Cell Lung Cancer (squamous or non-squamous);
✓. ECOG performance status of 0-2;
✓. Patients with evidence of:
✓. Any de novo stage IV NSCLC disease diagnosis as defined by AJCC 8th edition staging. Staged with PET/CT, MRI brain, or other acceptable staging tool; measurable disease as defined by RECIST 1.1;
✓. Adequate end-organ function, based on routine clinical and laboratory workup and institutional guidelines, as determined by oncology team offering patient standard of care therapy, including:
✓. ANC \>1,000 cells/µl, Platelets \> 100,000 cells/µl, Hemoglobin \> 10.0 g/dl;

Exclusion criteria

✕. Subjects with confirmed stage I-III NSCLC;
✕. Patients whose tumors have actionable mutations treatable with targeted therapies;
✕. Patients with no evidence of cancer cachexia, defined by the International Cancer Cachexia Consensus Definition (\>5% weight loss over the preceding 6 months prior to diagnosis); OR Patients with no evidence of cancer pre-cachexia, defined by the International Cancer Cachexia Consensus Definition (0 to \<=5% weight loss over the preceding 6 months prior to diagnosis);
✕. Active malignancy other than lung cancer that requires concurrent treatment other than hormonal therapy and is deemed by the treating physicians to be likely to affect the subject's survival duration;
✕. Subjects who have not recovered or have disease control from prior treatment-related to toxicities judged by treating physician;
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or other agents used in study;
✕. Uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements;
✕. Inadequate liver or renal function, if out of the acceptable ranges of the inclusion criteria;

What they're measuring

Number of non-small cell lung cancer cachexia patients with toxicity with the use of Ruxolitinib

Timeframe: 3 months

Trial details

NCT IDNCT04906746

SponsorTu Dan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-27

View on ClinicalTrials.gov More Stage IV Non-small Cell Lung Cancer trials