None listed
Conditions
Interventions
Drug : A combination of WK0202 capsules and XELOX or FOLFOX (mFOLFOX6) is administered.
Administration cycle: WK0202 capsules are orally administered once a day at a certain period of time (a.m. empty
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person who voluntarily agrees to participate in this clinical trial 2) An adult man or woman over the age of 19 3) A person diagnosed with colorectal cancer by pathology (histology or cytolo gy) 4) Patients requiring treatment with XELOX or FOLFOX (mFOLFOX6) therapy 5) Those who have an average BFI score of less than 4 points during a screenin g visit (except when one of all BFI items has a score of 7 or higher 6) Those who fall under Eastern Cooperative Oncology Group (ECOG) =1 7) Person who is able to be measured by Inbody during screening visit 8) If the person is female participant or female partner of male participant who has not undergone infertility surgery if she is fertile, those who agrees to follo wing contraception in the period of clinical trial and after the end of the clinica l trial at least 4 months for men and for at least 6 months women (1) For both female participant or female partner of male participant: Use of int rauterine device/tubal ligation and infertility surgery/condom or diaphragm and spermicide or combination use of birth control pill (2) For male participant(not applicable for male partner of female participant): use of condom (3) Absolute abstinence (Intermittent abstinence (e.g., during ovulation, sympt othermal method, or post ovulation) or coitus interruptus are not agreeing to a bstinence) 9) During a screening visit, laboratory test meets the follow criteria: (1) ANC = 1,500/mm³ (2) Platelet count =100,000/mm³ (3) Hemoglobin = 9.0 g/dL (if hemoglobin level is less than 9.0 g/dl, recover to 9.0 g/dL or higher; In such cases, participant may be registered at the discretion of the investigator. However, blood transfusions within 7 days are not allowed based on the screening time to satisfy this standard.) (4) Patients with TSH in normal range (however, participant that was administe red thyroid hormone without changing the usage and dose for at least 4 weeks prior to screening may be registered at the discretion of the investigator) (5) Creatine clearance = 60mL/min or eGFR = 60mL/min/1.73?
Exclusion criteria
Exclusion criteria: [Current disease and medical history] 1) A person who is scheduled to undergo radiotherapy during the clinical trial p eriod 2) A person who is unable to orally administer drugs or may affect the absorpti on of drugs for clinical trials 3) Patients with the following cardiovascular diseases during screening visits (1) Myocardial infarction or unstable angina within 6 months prior to screening visit (2) Congestion heart failure above class III according to the New York Heart Ass ociation (NYHA) classification (3) QTc interval = 450 msec or clinically significant ECG changes 4) A person who has undergone major surgery requiring general anesthesia wit hin 3 weeks prior to the screening visit 5) an HIV-positive patient 6) Patients with positive active hepatitis (HBV, HCV) test results 7) Patients with acute or severe infections 8) Patients who have experienced severe adverse reactions to drugs containing components of the same family as clinical trial drugs or have a history of allergi es 9) A person who lost more than 5% of weight within 6 months prior to the scr eening or has a Body Mass Index (BMI) of less than 20 kg/m² within 6 months prior to the screening visit and has a weight loss of more than 2% [Prohibited drugs] 10) A person who has taken the following drugs within 4 weeks prior to the screening visit: (1) Stimulants (Methylphenidate, Modafinil, etc.) (2) Antidepressants (such as Bupropion) (3) Herbal medicine or health functional food for fatigue control (such as red gi nseng) (4) another clinical trial drug [Others] 11) A person with a life expectancy of 6 months or less 12) Pregnant or lactating women 13) A person who participated in another clinical trial within 6 months prior to the screening visit 14) Any other person who was determined by the investigator that is unsuitabl e for this clinical trial due to clinically significant medical or psychiatric findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation and laboratory testing | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire evaluation and Inbody measurement;Biomarker evaluation (Cachexia-inducing factors, Muscle and Fat wating produ cts, Muscle fatigue and ATP dysregulation, Cytokine dysregulation, Male sex ho rmone, NQO1 genetic polymorphism(only for baseline;Pharmacokinetics | — |
Countries
Korea, Republic of
Contacts
Public ContactHye jeong Kim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed