Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers

Chong Kun Dang

Status and phase

Completed

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: CKD-516 inj.

Study type

Interventional

Funder types

Industry

Identifiers

NCT01560325

127ASC12A

Details and patient eligibility

About

A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection on twice-weekly schedule in patients with advanced solid cancers failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival and vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI) or DWI.

Full description

This is an open label, dose escalation study. Patients receive CKD-516 IV over 30 minutes on day 1, 4, 8, 11 every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3~6 patients receive escalating doses of CKD-516 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

Enrollment

21 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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