Safety and Pharmacokinetic Profile of CKD-581

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: CKD-581; Histone Deacetylase Inhibitors

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