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
Inclusion Criteria:
- 20~75 years
- Histologically or cytologically confirmed solid tumors that have failed to standard
therapy or for which no life prolonging treatment exists
- ECOG PS 0-2
- Life expectancy 12 weeks
- Hematopoietic: ANC ≥ 1,500/mm3, Platelet ≥ 100,000/mm3, Hemoglobin ≥ 9.0g/dL,
Prothrombin time, Activated partial thromboplastin time: normal range
- 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)
- serum creatinine ≤ 1.5×ULN or Creatinine clearance ≥ 60 mL/min
- PT, APTT: normal range
- Signed a written informed consent
Exclusion Criteria:
- Brain or Leptomeningeal metastases
- 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
- 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)
- Cerebrovascular disease such as stroke
- Grade 2 or greater motor or sensory peripheral neuropathy
- Uncontrolled hypertension(greater than 150 mmHg systolic or 100 mmHg diastolic
regardless of medication)
- acute infection or blooding tendencies that would preclude study compliance
- Serious vascular disease such as Aortic aneurysm
- Other psychiatric disorders or other conditions that would preclude study compliance
- Receiving anticoagulation with warfarin, heparin, etc.
- 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)
- Other concurrent antitumor therapy
- Patients with serious hypersensitivity history or allergy to CKD-516
- Pregnant or nursing, active serum pregnancy test. Fertile patients must use effective
contraception
- Participation in a clinical trial within 4 weeks of first dose of study drug
- Patients judged to be inappropriate for this study by the investigator with other
reasons