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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Chong Kun Dang Pharmaceutical.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 24, 2014