Safety and Pharmacokinetic Profile of CKD-581

NCT ID: NCT01580371

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-06-30

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.

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.

Conditions

Lymphoma; Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

CKD-581

Group Type: EXPERIMENTAL

CKD-581

Intervention Type: DRUG

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

Interventions

CKD-581

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

Intervention Type: DRUG

Other Intervention Names

Histone Deacetylase Inhibitor

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dok Hyun Yoon, Ph.D

Role: STUDY_CHAIR

88,Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea

Locations

ASAN Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

133HL/NHL11L

Identifier Type: -

Identifier Source: org_study_id