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in Patients With Lymphoma Failed to Standard Therapy (HL/NHL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01580371
First received: April 16, 2012
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Lymphoma
 Drug: CKD-581
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial to Assess the Safety and PK Profile of CKD-581 in Patients With Lymphoma Failed to Standard Therapy

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • MTD [ Time Frame: MTD: up to 28 days (1st cycle) ] [ Designated as safety issue: No ]
    •MTD, Maximum Tolerated Dose


Secondary Outcome Measures:
  • RR [ Time Frame: approximately 56 days(every 2 cycle) ] [ Designated as safety issue: No ]
    •ORR(%), Objective response rate

  • DLT [ Time Frame: up to 28 days(1st cycle) ] [ Designated as safety issue: Yes ]
    DLT: Dose Limiting Toxicity

  • PK [ 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) ] [ Designated as safety issue: No ]
    PK parameters(AUC, Cmax) of CKD-581 & metabolites

  • PFS [ Time Frame: up to progression ] [ Designated as safety issue: No ]
    PFS: Progression Free survival


Estimated Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CKD-581
Day 1, 8, 15 every 4 weeks
 Drug: CKD-581
Day 1, 8, 15 every 4 weeks
Other Name: HDACi

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 years and older
  • Histologically or cytologically confirmed Lymphoma that have failed to standard therapy or for which no life prolonging treatment exists
  • ECOG PS 0-2
  • Life expectancy 12 weeks
  • Hematopoietic: ANC ≥ 1,500/mm3, Platelet ≥ 100,000/mm3, Hemoglobin ≥ 9.0g/dL, Prothrombin time, Activated partial thromboplastin time: normal range
  • Hepatic: total bilirubin ≤ 1.5×ULN(except Gilbert's syndrome patients), AST, ALT ≤ 3.0×ULN(AST, ALT ≤ 5.0×ULN in case of liver metastases)
  • Renal: serum creatinine ≤ 1.5×ULN
  • 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
  • History of HDAC agent
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580371

Locations
Korea, Republic of
ASAN Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01580371     History of Changes
Other Study ID Numbers: 133HL/NHL11L
Study First Received: April 16, 2012
Last Updated: April 17, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013