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Spots Global Cancer Trial Database for NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

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Trial Identification

Brief Title: NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

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

Study ID: NCT02300467

Interventions

NOV120401

Study Description

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.

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.

Keywords

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of

Contact Details

Name: Jung Yong Kim, MD

Affiliation: National OncoVenture (jyk1949@ncc.re.kr)

Role: STUDY_DIRECTOR

Name: Min Chae Kim, Pharmacist

Affiliation: National OncoVenture (minchae@ncc.re.kr)

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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