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Active Not Recruiting
NCT04906746
Ruxolitinib for Cancer Cachexia
Conditions: Stage IV Non-small Cell Lung Cancer, Cachexia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 10
Sponsor: Tu Dan
Location: UT Southwestern Medical Center Dallas Texas
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.
Eligibility Criteria
Inclusion Criteria:
1. Male or female subjects at least 18 years of age;
2. Ability to understand and the willingness to sign a written informed consent;
3. Histological or biopsy proven Non-Small Cell Lung Cancer (squamous or non-squamous);
4. ECOG performance status of 0-2;
5. 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 \1,000 cells/µl, Platelets \> 100,000 cells/µl, Hemoglobin \> 10.0 g/dl;
2. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 45 ml/min;
3. Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN;
4. 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;
8. 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);
9. Male subjects who are surgically sterile or are using a medically acceptable form of contraception for 90 days following the completion of therapy;
10. Life expectancy anticipated to be 6 months or greater;
11. No prior therapy for advanced lung cancer.
Exclusion Criteria:
1. Subjects with confirmed stage I-III NSCLC;
2. Patients whose tumors have actionable mutations treatable with targeted therapies;
3. 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 \
Source: ClinicalTrials.gov (NCT04906746). StuddyBuddy aggregates publicly available trial information.