Know Cancer

forgot password

Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-516 in Patients With Advanced Solid Cancers Failed to Standard Therapy

Phase 1
20 Years
75 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-516 in Patients With Advanced Solid Cancers Failed to Standard Therapy


- I. Determine the maximum tolerated dose of CKD-516 administered at single doses every
21 days in patients with advanced solid tumors.

- II. Determine both the toxicity and dose limiting toxicity of this regimen in these

- III. Determine the plasma and urine pharmacokinetics of CKD-516.

- IV. Gather preliminary data regarding possible antitumor effects in those patients with
measurable diseae. Assess the effects of CKD-516 on tumor blood flow using DCE-MRI
scanning techniques, and establish the dose at which these effects occur.

OUTLINE: This is an open label, dose escalation study. Patients receive CKD-516 IV over 30
minutes on day 1, 8 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.

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)

- Renal: serum creatinine ≤ 1.5×ULN or Creatinine clearance ≥ 60 mL/min

- 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

- Clinically significant eye diseases(e.g., Glaucoma or Proliferative diabetic
retinopathy, Atrophic macular degeneration), or other clinically significant
abnormality on screening visit

- Uncontrolled hypertension(greater than 150 mmHg systolic anc 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 4 weeks
prior to first dose of study drug(6 weeks for nitrosoureas and mitomycin C, 2 weeks
for radiation therapy)

- Other concurrent antitumor therapy

- History of Serious hypersensitivity or allergy

- Pregnant or nursing, active serum pregnancy test. Fertile patients must use effective

- Participation in a clinical trial within 4 weeks of first dose of study drug

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD, Maximum Tolerated Dose

Outcome Time Frame:

1st cycle

Safety Issue:


Principal Investigator

Yung-Jue Bang, MD., PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

December 2009

Completion Date:

April 2011

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Tubulin polymerization inhibitor
  • CKD-516
  • Phase I
  • Vascular disrupting agent