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

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ClinicalTrials.gov Identifier: NCT01028859
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 22, 2011
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by:
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 a 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).

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

Detailed Description:

OBJECTIVES:

  • 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 patients.
  • 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 in Patients With Advanced Solid Cancers Failed to Standard Therapy
Study Start Date : December 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: CKD-516 inj Drug: CKD-516 inj
5.0 mg/2ml; 1.0, 2.0, 3.3, 5, 7, 9 ~ mg/m2; Day 1, Day 8 every 3 weeks
Other Name: CKD-516




Primary Outcome Measures :
  1. MTD, Maximum Tolerated Dose [ Time Frame: 1st cycle ]
  2. PK parameters of CKD-516 and its metabolite, S516, when CKD-516 administered on Days 1 and 8 of a 21-day cycle [ Time Frame: 1st cycle ]
  3. Dose-limiting Toxicity [ Time Frame: 1st cycle ]

Secondary Outcome Measures :
  1. ORR%, Objective response rate [ Time Frame: every 2 cycle ]
  2. PFS, Progression Free Survival [ Time Frame: 30 days before or after last patient out ]
  3. Vascular disruption effect(with DCE-MRI) [ Time Frame: 24hr after 1st cycle day 1 treatment ]


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01028859


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Seoul National University Hospital
Investigators
Principal Investigator: Yung-Jue Bang, MD., PhD. Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chong Kun Dang Pharmaceutical, Medical Department
ClinicalTrials.gov Identifier: NCT01028859     History of Changes
Other Study ID Numbers: 127ASC09E
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 22, 2011
Last Verified: December 2009

Keywords provided by Chong Kun Dang Pharmaceutical:
Tubulin polymerization inhibitor
CKD-516
Phase I
Vascular disrupting agent
DCE MRI