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

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0000499
• Lead Sponsor: Chong Kun Dang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MTD(Maximum Tolerated Dose) ;DLT(Dose-Limiting Toxicity) ;PK parameter

Secondary Outcome Measures

Name	Time	Method
Ani- tumor effect: Objective Response Rate, Progression Free Survival, Overall Survival;Vascular disruption effect(Image and Biomarker)