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Phase I Clinical Trial to Assess the Safety and PK Profile of CKD-581 in Patients With Lymphoma Failed to Standard Therapy

Phase 1
20 Years
Open (Enrolling)

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Trial Information

Phase I Clinical Trial to Assess the Safety and PK Profile of CKD-581 in Patients With Lymphoma Failed to Standard Therapy

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.

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

- Participation in a clinical trial within 4 weeks of first dose of study drug

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

•MTD, Maximum Tolerated Dose

Outcome Time Frame:

MTD: up to 28 days (1st cycle)

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

May 2013

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Lymphoma