Status:
ACTIVE_NOT_RECRUITING
Ruxolitinib for Cancer Cachexia
Lead Sponsor:
Tu Dan
Collaborating Sponsors:
Incyte Corporation
Conditions:
Stage IV Non-small Cell Lung Cancer
Cachexia
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 cache...
Detailed Description
Lung cancer patients on a whole, and a significant percentage of NSCLC patients in particular, develop cancer cachexia. In fact, approximately 30-40% of all NSCLC patients will develop cachexia in the...
Eligibility Criteria
Inclusion
- 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:
- cancer cachexia, defined by the International Cancer Cachexia Consensus Definition (\>5% weight loss over the preceding 6 months prior to diagnosis); OR
- Patients with 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);
- 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;
- Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 45 ml/min;
- Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN;
- International normalized ratio (INR) (or prothrombin time (PT)) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, if values are within the intended therapeutic range;
- Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: a. Has not undergone a hysterectomy or bilateral oophorectomy; or b. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months);
- Male subjects who are surgically sterile or are using a medically acceptable form of contraception for 90 days following the completion of therapy;
- Life expectancy anticipated to be 6 months or greater;
- No prior therapy for advanced lung cancer.
Exclusion
- 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;
- Significant bacterial, fungal, parasitic, or viral infection requiring treatment;
- Previous treatment with a JAK inhibitor;
- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of ruxolitinib;
- Females who are pregnant, breast-feeding or plan to become pregnant;
- Participation in other clinical trials either to treat diagnosed lung or other cancers (patients on registry trials are eligible);
- Requirement for treatment with drugs that may, in the judgment of the treating investigator, create a risk for a precipitous change in patient's health;
- Any other conditions that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study;
- Life expectancy of less than 6 months;
- Prior therapy for the newly diagnosed advanced lung cancer.
- Patients taking therapies that are strong CYP3A4 inhibitors and fluconazole.
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04906746
Start Date
February 23 2022
End Date
December 1 2025
Last Update
July 28 2025
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390