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UNKNOWNPHASE1

NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of NOV120401 (CKD-516 Tablet) in Patients With Advanced Refractory Solid Tumors

NCT02300467•National OncoVenture

View on ClinicalTrials.gov

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.

Detailed Description

Vascular disrupting agents are expected to kill cancer cells located in core of tumor tissues by disrupting microvascular structure of tumor. To assess the safety and tolerability of NOV120401 (CKD-516 Tablet), patients with advanced refractory solid tumors will be enrolled in this study. Initial dose of NOV120401 (CKD-516 Tablet) is 5 mg/day, which will be escalated until at least 2 of 6 subjects show dose-limiting toxicities (DLTs). Pharmacokinetic profiles and efficacy by tumor response and vascular disrupting activities will also be assessed.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. 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)
•2. 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)
•3. 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.)
•4. 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)
•5. Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months
•6. Uncontrolled arrhythmia
•7. Significant cerebrovascular diseases including stroke within 6 months
•8. Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases
•9. Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease
•10. 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
+5 more criteria

Locations (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Key Dates

Start Date

December 1, 2014

Primary Completion Date

July 1, 2016

Completion Date

July 1, 2016

Last Updated

August 14, 2015

Enrollment

ESTIMATED participants

Conditions

Advanced Refractory Solid Tumors

Interventions

NOV120401

DRUG

Contacts

Hark Kyun Kim, MD, PhD

CONTACT

hkim@ncc.re.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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