Advanced Refractory Solid TumorsPhase 1NCT02300467
NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors
A Phase 1 study testing NOV120401 in people with Advanced Refractory Solid Tumors, run by National OncoVenture at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Refractory Solid Tumors
- What is being tested?
- NOV120401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 19 years or older
- Patients who failed existing anti-cancer therapies
- ECOG performance status ≤ 2
- Life expectancy of ≥ 12 weeks
- Adequate hematological, hepatic and renal functions:
- Patients who give written informed consent voluntarily
Who cannot join
- 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)
- 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)
- 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.)
- 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)
- Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months
- Uncontrolled arrhythmia
Show all 15Show fewer
- Significant cerebrovascular diseases including stroke within 6 months
- Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases
- Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease
- 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
- A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP
- Pregnancy or breast-feeding
- 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
- Patients who received other investigational products or used other investigational devices within 3 weeks before participation
- Patients who cannot participate in this trial by investigator's discretion
Trial locations and contacts
1 site in 1 country.
Hark Kyun Kim, MD, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Hark Kyun Kim, MD, PhD, hkim@ncc.re.kr
Hark Kyun Kim, MD, PhD
About this study
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
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.
Read the 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
- Being tested
- NOV120401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOV120401Drug
Also called CKD-516 Tablet
5 to 45 mg/day PO for 5 consecutive days and 2 days off
| Study group | Role | What they receive |
|---|---|---|
| NOV120401 (CKD-516 Tablet) | Experimental | 5 to 45 mg/day PO for 5 consecutive days and 2 days off Receives: Drug: NOV120401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and MTD/recommended phase 2 dose (RP2D) determination (Number of Participants with Adverse Events)
Number of Participants with Adverse Events
Measured: By 40 weeks after enrollment of the last subject
Secondary outcomes (4)
Pharmacokinetic profiles (Cmax, Tmax, AUClast, AUCinf, t1/2, CL, MRT, Ctrough) of CKD-516 and S516 (active metabolite of CKD-516)
Measured: 21 days
Tumor response
Measured: up to 36 weeks
Vascular disrupting activity measured by tubulin status (western blot from peripheral blood mononuclear cell)
western blot from peripheral blood mononuclear cell
Measured: 21 days
Vascular disrupting activity measured by plasma factor (VEGF, G-CSF, GM-CSF, SDF-1) concentration from serum
concentration from serum
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National OncoVenture
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Jung Yong Kim, MD, Study director, National OncoVenture (jyk1949@ncc.re.kr)Min Chae Kim, Pharmacist, Study director, National OncoVenture (minchae@ncc.re.kr)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300467
- Sponsor's protocol ID
- NOV120401-101
- Status last verified
- Aug 2015
- First submitted
- 18 Nov 2014
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02300467
- Acronym / sponsor ID
- NOV120401-101
- Conditions
- Advanced Refractory Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National OncoVentureUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOV120401 (CKD-516 Tablet) | Experimental | Drug: NOV1204015 to 45 mg/day PO for 5 consecutive days and 2 days off |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 19 years or older
- Patients who failed existing anti-cancer therapies
- ECOG performance status ≤ 2
- Life expectancy of ≥ 12 weeks
- Adequate hematological, hepatic and renal functions:
Key exclusion criteria (15 listed)
- 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)
- 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)
- 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.)
- 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)
- Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOV120401Also: CKD-516 Tablet5 to 45 mg/day PO for 5 consecutive days and 2 days off | Drug | NOV120401 (CKD-516 Tablet) |
Primary outcome
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
4 secondary outcomes
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
Tumor response
Time frame: up to 36 weeks
Vascular disrupting activity measured by tubulin status (western blot from peripheral blood mononuclear cell)
Time frame: 21 days
Vascular disrupting activity measured by plasma factor (VEGF, G-CSF, GM-CSF, SDF-1) concentration from serum
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hark Kyun Kim, MD, PhD contact
Jung Yong Kim, MD study director
National OncoVenture (jyk1949@ncc.re.kr)
Min Chae Kim, Pharmacist study director
National OncoVenture (minchae@ncc.re.kr)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NOV120401 in people with Advanced Refractory Solid Tumors, run by National OncoVenture at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hark Kyun Kim, MD, PhD (hkim@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.