NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

• Sponsor: National OncoVenture (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02300467
• Collaborator: Chong Kun Dang Pharmaceutical (Industry)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 19
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Refractory Solid Tumors	Drug: NOV120401	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2014
• Anticipated Primary Completion Date: Jul 1, 2016
• Anticipated Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NOV120401 (CKD-516 Tablet) 5 to 45 mg/day PO for 5 consecutive days and 2 days off	Drug: NOV120401; 5 to 45 mg/day PO for 5 consecutive days and 2 days off; Other Names: CKD-516 Tablet

Outcome Measures

Primary Outcome Measures

1. Safety and MTD/recommended phase 2 dose (RP2D) determination (Number of Participants with Adverse Events) [By 40 weeks after enrollment of the last subject]

   Number of Participants with Adverse Events

Secondary Outcome Measures

1. Pharmacokinetic profiles (Cmax, Tmax, AUClast, AUCinf, t1/2, CL, MRT, Ctrough) of CKD-516 and S516 (active metabolite of CKD-516) [21 days]

2. Tumor response [up to 36 weeks]

3. Vascular disrupting activity measured by tubulin status (western blot from peripheral blood mononuclear cell) [21 days]

   western blot from peripheral blood mononuclear cell

4. Vascular disrupting activity measured by plasma factor (VEGF, G-CSF, GM-CSF, SDF-1) concentration from serum [21 days]

   concentration from serum

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	410-769

Sponsors and Collaborators

• National OncoVenture
• Chong Kun Dang Pharmaceutical

Investigators

• Study Director: Jung Yong Kim, MD, National OncoVenture ([e-mail])
• Study Director: Min Chae Kim, Pharmacist, National OncoVenture ([e-mail])

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National OncoVenture
• ClinicalTrials.gov Identifier: NCT02300467
• Other Study ID Numbers: NOV120401-101
• First Posted: Nov 25, 2014
• Last Update Posted: Aug 14, 2015
• Last Verified: Aug 1, 2015

• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Aug 14, 2015