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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01560325
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : September 16, 2015
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: CKD-516 inj. Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2012
Primary Completion Date : October 2014
Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: CKD-516 inj.
CKD-516 Inj, 3.3~13mg/m2/day, D1, 4, 8, 11 every 3 weeks
Drug: CKD-516 inj.
CKD-516: 3.3~13mg/m2/day
Other Name: CKD-516

Primary Outcome Measures :
  1. MTD, Maximum Tolerated Dose [ Time Frame: up to 21days ]

Secondary Outcome Measures :
  1. PK parameter of CKD-516 [ Time Frame: 0(Pre-dose), 24hrs post dose (Day 1), 0, 0.5, 4, 8, 24hours post-dose(Day 11) ]
  2. DLT, Dose-limiting Toxicity [ Time Frame: up to 21days ]
  3. ORR%, Objective response rate [ Time Frame: up to 42weeks ]
  4. Vascular disruption effect [ Time Frame: 4hr, 24hr post-dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01560325

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Principal Investigator: Yung-Jue Bang Seoul National University Hospital

Responsible Party: Chong Kun Dang Pharmaceutical Identifier: NCT01560325     History of Changes
Other Study ID Numbers: 127ASC12A
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: August 2015

Keywords provided by Chong Kun Dang Pharmaceutical:
Solid Tumor, Tubulin inhibitor