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Colorectal CancerPhase 1/2NCT03076957

A Phase 1/2a Study to Assess the Safety and Efficacy of CKD-516 Tab. in Combination With Irinotecan Inj.

A Phase 1/2 study testing CKD-516 Tablet in people with Colorectal Cancer, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 CKD-516 Tablet in Combination with Irinotecan inj. in Patients with Previously Treated Advanced Colorectal Cancer Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
CKD-516 Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSouth Korea
Study dates
Dec 2016to Jun 2019
Phase
Phase 1/2
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 ≤ 1
  • 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 3 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.

Tae won KIM, MD contact

twkimmd@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul

    Tae won KIM, MD, twkimmd@amc.seoul.kr

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase 1/2a Study to Assess the Safety and Efficacy of CKD-516 Tab. in Combination With Irinotecan Inj. in Patients With Previously Treated Advanced Colorectal Cancer

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 CKD-516 Tablet in Combination with Irinotecan inj. in Patients with Previously Treated Advanced Colorectal Cancer

Read the detailed description

CKD-516 tab. in combination with Irinotecan inj.(1cycle=14days)

Being tested
CKD-516 Tablet
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-516 TabletDrug

    Also called CKD-516

    CKD-516 PO for 5 consecutive days and 2 days off in Combination with Irinotecan inj.

Study groups in NCT03076957
Study groupRoleWhat they receive
Treat RegimenExperimentalCKD-516(investigational Drug) Irinotecan
Receives: Drug: CKD-516 Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose(MTD)

    Measured: Up to 14 days(for 1st cycle)

Secondary outcomes (2)

  1. Pharmacokinetics(Cmax)

    Measured: 1st Cycle Day1: up to 24hr

  2. Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2017
  2. Study startDec 2016
  3. Primary completionJun 2018 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03076957
Sponsor's protocol ID
127CRC16009
Status last verified
Mar 2017
First submitted
22 Dec 2016
Last updated
10 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Jeong H, Hong YS, Kim JE, Lim HS, Ahn JB, Shin SJ, Park YS, Kim ST, Han SW, Kim TY, Kim TW. A phase 1 dose-escalation and dose-expansion study to assess the safety and efficacy of CKD-516, a novel vascular disrupting agent, in combination with Irinotecan in patients with previously treated metastatic colorectal cancer. Invest New Drugs. 2021 Oct;39(5):1335-1347. doi: 10.1007/s10637-021-01110-9. Epub 2021 Apr 7.

    PubMed 33829355

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CKD-516 Tablet in people with Colorectal Cancer, run by Chong Kun Dang Pharmaceutical 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 10 Mar 2017. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Tae won KIM, MD (twkimmd@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose(MTD) (time frame: Up to 14 days(for 1st cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03076957, which also lists 1 linked publication.

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 10 Mar 2017.

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