NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

NCT ID: NCT02300467

Last Updated: 2015-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-07-31

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.

Conditions

Advanced Refractory Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NOV120401 (CKD-516 Tablet)

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

Group Type: EXPERIMENTAL

NOV120401

Intervention Type: DRUG

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

Interventions

NOV120401

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

Intervention Type: DRUG

Other Intervention Names

CKD-516 Tablet

Eligibility Criteria

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

11. A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP

12. Pregnancy or breast-feeding

13. 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

14. Patients who received other investigational products or used other investigational devices within 3 weeks before participation

15. Patients who cannot participate in this trial by investigator's discretion

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

National OncoVenture

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jung Yong Kim, MD

Role: STUDY_DIRECTOR

National OncoVenture (jyk1949@ncc.re.kr)

Min Chae Kim, Pharmacist

Role: STUDY_DIRECTOR

National OncoVenture (minchae@ncc.re.kr)

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hark Kyun Kim, MD, PhD

Role: CONTACT

hkim@ncc.re.kr

Facility Contacts

Hark Kyun Kim, MD, PhD

Role: primary

hkim@ncc.re.kr

Other Identifiers

NOV120401-101

Identifier Type: -

Identifier Source: org_study_id