KCT0000499Recruiting未知
Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-516 inj. Administered on A Twice-Weekly Schedule in Patients with Advanced Solid Cancers Failed to Standard Therapy
Chong Kun Dang0 sites24 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 75(Year) (—)
- Sex
- All
Inclusion Criteria
- •1. 20~75 years
- •2. Histologically or cytologically confirmed solid tumors that have failed to standard therapy or for which no life prolonging treatment exists
- •3. ECOG PS 0-2
- •4. Life expectancy 12 weeks
- •5. Hematopoietic: ANC >/= 1,500/mm3, Platelet >/= 100,000/mm3, Hemoglobin >/= 9.0g/dL, Prothrombin time, Activated partial thromboplastin time: normal range
- •6. Hepatic: total bilirubin =/< 1.5×ULN(except Gilbert's syndrome patients), AST, ALT =/< 3.0×ULN(AST, ALT =/< 5.0×ULN in case of liver metastases)
- •7. PT, APTT: normal range
- •8. Signed a written informed consent
Exclusion Criteria
- •1. Brain or Leptomeningeal metastases
- •2. History of Ischemic heart disease(e.g., myocardial infarction, unstable angina pectoris) or Clinically significant heart disease such as NYHA Class III and IV Congestive atrial arrhythmias, within 6 months prior to first dose of study drug
- •3. Stable angina pectoris shown symptoms within 6 months prior to first dose of study durg, or Clinically significant abnormality on EKG or echocardiogram(e.g., LVEF < 50% or clinically significant heart wall abnormality or heart muscle damage)
- •4. Cerebrovascular disease such as stroke
- •5. Grade 2 or greater motor or sensory peripheral neuropathy
- •6. Uncontrolled hypertension(greater than 150 mmHg systolic or 100 mmHg diastolic regardless of medication)
- •7. acute infection or blooding tendencies that would preclude study compliance
- •8. Serious vascular disease such as Aortic aneurysm
- •9. Other psychiatric disorders or other conditions that would preclude study compliance
- •10. Receiving anticoagulation with warfarin, heparin, etc.
- •11. Receiving antitumor therapy(surgery, immunotherapy or chemotherapy) within 3 weeks prior to first dose of study drug(6 weeks for nitrosoureas and mitomycin C, 2 weeks for radiation therapy)
- •12. Other concurrent antitumor therapy
- •13. Patients with serious hypersensitivity history or allergy to CKD-516
- •14. Pregnant or nursing, active serum pregnancy test. Fertile patients must use effective contraception
- •15. Patients who prohibit being administered due to medical and psychological condition
- •16. Patient not allowed to participate in study legally
- •17. Participation in a clinical trial within 4 weeks of first dose of study drug
- •18. Patients judged to be inappropriate for this study by the investigator with other reasons
Investigators
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