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NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02300467
Recruitment Status : Unknown
Verified August 2015 by National OncoVenture.
Recruitment status was:  Recruiting
First Posted : November 25, 2014
Last Update Posted : August 14, 2015
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
National OncoVenture

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : December 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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 Name: CKD-516 Tablet




Primary Outcome Measures :
  1. Safety and MTD/recommended phase 2 dose (RP2D) determination (Number of Participants with Adverse Events) [ Time Frame: 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) [ Time Frame: 21 days ]
  2. Tumor response [ Time Frame: up to 36 weeks ]
  3. Vascular disrupting activity measured by tubulin status (western blot from peripheral blood mononuclear cell) [ Time Frame: 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 [ Time Frame: 21 days ]
    concentration from serum



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300467


Contacts
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Contact: Hark Kyun Kim, MD, PhD hkim@ncc.re.kr

Locations
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Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Hark Kyun Kim, MD, PhD       hkim@ncc.re.kr   
Principal Investigator: Hark Kyun Kim, MD, PhD         
Sponsors and Collaborators
National OncoVenture
Chong Kun Dang Pharmaceutical
Investigators
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Study Director: Jung Yong Kim, MD National OncoVenture (jyk1949@ncc.re.kr)
Study Director: Min Chae Kim, Pharmacist National OncoVenture (minchae@ncc.re.kr)

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Responsible Party: National OncoVenture
ClinicalTrials.gov Identifier: NCT02300467     History of Changes
Other Study ID Numbers: NOV120401-101
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: August 14, 2015
Last Verified: August 2015