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

NCT01028859 | Completed Phase 1 DMC

• 1 other identifier: 127ASC09E
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

Tubulin polymerization inhibitor; CKD-516; Phase I; Vascular disrupting agent; DCE MRI

Outcome Measures

Primary Outcomes (3)

• MTD, Maximum Tolerated Dose

  1st cycle

• PK parameters of CKD-516 and its metabolite, S516, when CKD-516 administered on Days 1 and 8 of a 21-day cycle

  1st cycle

• Dose-limiting Toxicity

  1st cycle

Secondary Outcomes (3)

• ORR%, Objective response rate

  every 2 cycle

• PFS, Progression Free Survival

  30 days before or after last patient out

• Vascular disruption effect(with DCE-MRI)

  24hr after 1st cycle day 1 treatment

Study Arms (1)

CKD-516 inj

EXPERIMENTAL

Drug: CKD-516 inj

Interventions

CKD-516 inj DRUG

5.0 mg/2ml; 1.0, 2.0, 3.3, 5, 7, 9 \~ mg/m2; Day 1, Day 8 every 3 weeks

Also known as: CKD-516

CKD-516 inj

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Kim KW, Lee JM, Jeon YS, Kang SE, Baek JH, Han JK, Choi BI, Bang YJ, Kiefer B, Block KT, Ji H, Bauer S, Kim C. Free-breathing dynamic contrast-enhanced MRI of the abdomen and chest using a radial gradient echo sequence with K-space weighted image contrast (KWIC). Eur Radiol. 2013 May;23(5):1352-60. doi: 10.1007/s00330-012-2699-4. Epub 2012 Nov 28.

  PMID: 23187728 DERIVED

MeSH Terms

Interventions

N-(4-(3-(1H-1,2,4-triazol-1-yl)-4-(3,4,5-trimethoxybenzoyl)phenyl)thiazol-2-yl)-2-amino-3-methylbutanamide

Study Officials

• Yung-Jue Bang, MD., PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 9, 2009
• Study Start: December 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 22, 2011

Record last verified: 2009-12

Locations

KR (1)