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LymphomaPhase 1CKD-581NCT01580371

Safety and Pharmacokinetic Profile of CKD-581

A Phase 1 study testing CKD-581 in people with Lymphoma and Multiple Myeloma, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with Lymphoma failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Lymphoma, Multiple Myeloma
What is being tested?
CKD-581
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteSouth Korea
Study dates
May 2012to Jun 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 20 years and older
  • Histologically or cytologically confirmed Lymphoma or Multiple myeloma that have failed to standard therapy or for which no life prolonging treatment exists
  • ECOG(Eastern cooperative oncology) performance status ≤ 2
  • Life expectancy 12 weeks
  • Hematopoietic: ANC(Absolute Neutrophil Count) ≥ 1,500/mm3, Platelet count(PLT) ≥ 100,000/mm3, Hemoglobin ≥ 9.0g/dL
  • Hepatic: Total bilirubin > 1.5×upper limit of normal(except Gilbert's syndrome patients), aspartate aminotransferase(AST) > 3×upper limit of normal, alanine aminotransferase(ALT) > 3×upper limit of normal(AST, ALT ≤ 5.0×ULN in case of liver metastases)
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  • Renal: serum creatinine ≤ 1.5×upper limit of normal
  • Serum calcium ≤ upper limit of normal (If the Multiple myeloma only)
  • Signed a written informed consent

Who cannot join

  • Have symptoms with Brain metastases
  • History of Ischemic heart disease(e.g., myocardial infarction, unstable angina pectoris) or Clinically significant heart disease such as NYHA Class III and IV Congestive atrial arrhythmias, within 6 months prior to first dose of study drug
  • Acute infection or blooding tendencies that would preclude study compliance
  • Other psychiatric disorders or other conditions that would preclude study compliance
  • Receiving antitumor therapy(surgery, immunotherapy or chemotherapy) within 4 weeks prior to first dose of study drug(6 weeks for nitrosoureas and mitomycin C, 2 weeks for radiation therapy)
  • Other concurrent antitumor therapy
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  • Have Cardiac disease by nature
  • Administration history of Histone Deacetylase Inhibitor
  • History of Serious hypersensitivity or allergy
  • Pregnant or nursing, active serum pregnancy test. Fertile patients must use effective contraception
  • Participation in a clinical trial within 4 weeks of first dose of study drug

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • ASAN Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-581 in Patients With Lymphoma or Multiple Myeloma Failed to Standard Therapy

This study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with Lymphoma failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival.

Read the detailed description

Recently, the role of transcriptional repression through epigenetic modulation in carcinogenesis has been clinically validated with several inhibitors of histone deacetylases and DNA methyltransferases. It has long been recognized that epigenetic alterations of tumor suppressor genes was one of the contributing factors in carcinogenesis. Inhibitors of histone deacetylase (HDAC) de-repress genes that subsequently result in growth inhibition, differentiation and apoptosis of cancer cells. CKD-581 is developed for HDAC inhibitors. Such as to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with Lymphoma failed to standard therapy.

Being tested
CKD-581
Medical subject headings
Lymphoma, Multiple Myeloma

What participants receive

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

  • CKD-581Drug

    Also called Histone Deacetylase Inhibitor

    CKD-581 qd for Day 1, 8 and 15 every 28days/Cycle

Study groups in NCT01580371
Study groupRoleWhat they receive
TreatmentExperimentalCKD-581
Receives: Drug: CKD-581

What is being measured

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

  1. Maximum Tolerated Dose

    Measured: Up to 28 days (For 1st cycle)

Secondary outcomes (4)

  1. Dose Limiting Toxicity

    Measured: Up to 28 days (For 1st cycle)

  2. Pharmacokinetics

    PK parameters(AUC, Cmax) of CKD-581 \& metabolites

    Measured: 0, 0.25, 1, 1.5, 2, 2.25, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hrs post dose(1st cycle Day1, 15)

  3. Objective response rate

    Measured: every 56 days (every 2 cycle)

  4. Progression Free survival

    Measured: up to progression

Timeline

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

  1. First posted19 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionMar 2016
  4. Study completionJun 2016

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01580371
Sponsor's protocol ID
133HL/NHL11L
Acronym
CKD-581
Status last verified
Oct 2016
First submitted
16 Apr 2012
Last updated
6 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-581 in people with Lymphoma and Multiple Myeloma, 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 6 Oct 2016. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (time frame: Up to 28 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 NCT01580371.

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 6 Oct 2016.

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