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Safety and Pharmacokinetic Profile of CKD-581 (CKD-581)

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ClinicalTrials.gov Identifier: NCT01580371
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma Multiple Myeloma Drug: CKD-581 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
CKD-581
Drug: CKD-581
CKD-581 qd for Day 1, 8 and 15 every 28days/Cycle
Other Name: Histone Deacetylase Inhibitor




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: Up to 28 days (For 1st cycle) ]

Secondary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: Up to 28 days (For 1st cycle) ]
  2. Pharmacokinetics [ Time Frame: 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) ]
    PK parameters(AUC, Cmax) of CKD-581 & metabolites

  3. Objective response rate [ Time Frame: every 56 days (every 2 cycle) ]
  4. Progression Free survival [ Time Frame: up to progression ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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
  • 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

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): NCT01580371


Locations
Korea, Republic of
ASAN Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Study Chair: Dok Hyun Yoon, Ph.D 88,Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01580371     History of Changes
Other Study ID Numbers: 133HL/NHL11L
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action