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

NCT01560325 | Completed Phase 1

• 1 other identifier: 127ASC12A
• Study Type: interventional
• Target: 21
• 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 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

Solid Tumor, Tubulin inhibitor

Outcome Measures

Primary Outcomes (1)

• MTD, Maximum Tolerated Dose

  up to 21days

Secondary Outcomes (4)

• PK parameter of CKD-516

  0(Pre-dose), 24hrs post dose (Day 1), 0, 0.5, 4, 8, 24hours post-dose(Day 11)

• DLT, Dose-limiting Toxicity

  up to 21days

• ORR%, Objective response rate

  up to 42weeks

• Vascular disruption effect

  4hr, 24hr post-dose

Study Arms (1)

CKD-516 inj.

EXPERIMENTAL

CKD-516 Inj, 3.3\~13mg/m2/day, D1, 4, 8, 11 every 3 weeks

Drug: CKD-516 inj.

Interventions

CKD-516 inj. DRUG

CKD-516: 3.3\~13mg/m2/day

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)
• serum creatinine ≤ 1.5×ULN or Creatinine clearance ≥ 60 mL/min
• PT, APTT: normal range
• 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
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

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

  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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 22, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 16, 2015

Record last verified: 2015-08

Locations

KR (1)