NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

NCT02300467 | Unknown Phase 1

• 1 other identifier: NOV120401-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety, tolerability and pharmacokinetic profiles and to assess the efficacy of NOV120401 (CKD-516 Tablet), a novel vascular disrupting agent, in patients with advanced refractory solid tumors.

Conditions

Advanced Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and MTD/recommended phase 2 dose (RP2D) determination (Number of Participants with Adverse Events)

  Number of Participants with Adverse Events

  By 40 weeks after enrollment of the last subject

Secondary Outcomes (4)

• Pharmacokinetic profiles (Cmax, Tmax, AUClast, AUCinf, t1/2, CL, MRT, Ctrough) of CKD-516 and S516 (active metabolite of CKD-516)

  21 days

• Tumor response

  up to 36 weeks

• Vascular disrupting activity measured by tubulin status (western blot from peripheral blood mononuclear cell)

  21 days

• Vascular disrupting activity measured by plasma factor (VEGF, G-CSF, GM-CSF, SDF-1) concentration from serum

  21 days

Study Arms (1)

NOV120401 (CKD-516 Tablet)

EXPERIMENTAL

5 to 45 mg/day PO for 5 consecutive days and 2 days off

Drug: NOV120401

Interventions

NOV120401 DRUG

5 to 45 mg/day PO for 5 consecutive days and 2 days off

Also known as: CKD-516 Tablet

NOV120401 (CKD-516 Tablet)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 19 years or older
• Patients who failed existing anti-cancer therapies
• ECOG performance status ≤ 2
• Life expectancy of ≥ 12 weeks
• Adequate hematological, hepatic and renal functions:
• Patients who give written informed consent voluntarily

You may not qualify if:

• Prior systemic chemo-, radiochemo-, radio-, immuno-, hormonal and/or biological therapy within 2 weeks before study participation (in case of nitrosoureas and/or mitomycin, within 6 weeks before study participation)
• Patients who received major surgery within 4 weeks before study participation (in case of VATS and/or ONC surgery, within 2 weeks before study participation)
• Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.)
• NYHA class III or IV heart failure, uncontrolled hypertension (SBP/DBP \> 140/90 mm Hg), other clinically significant cardiovascular abnormalities at investigator's discretion (e.g., LVEF \< 50%, clinically significant cardiac wall abnormalities or cardiac muscle damages)
• Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months
• Uncontrolled arrhythmia
• Significant cerebrovascular diseases including stroke within 6 months
• Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases
• Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease
• Patients who cannot receive IP by mouth and have a history of clinically significant gastrointestinal disorders which can impede administration, transit or absorption of the IP
• A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP
• Pregnancy or breast-feeding
• Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
• Patients who received other investigational products or used other investigational devices within 3 weeks before participation
• Patients who cannot participate in this trial by investigator's discretion

Sponsors & Collaborators

• National OncoVenture: lead
• Chong Kun Dang Pharmaceutical: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

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

• Jung Yong Kim, MD

  National OncoVenture (jyk1949@ncc.re.kr)

  STUDY DIRECTOR

• Min Chae Kim, Pharmacist

  National OncoVenture (minchae@ncc.re.kr)

  STUDY DIRECTOR

Central Study Contacts

Hark Kyun Kim, MD, PhD

CONTACT

hkim@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 25, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 14, 2015

Record last verified: 2015-08

Locations

KR (1)