Back to results

Safety and Pharmacokinetic Profile of CKD-581 (CKD-581)

Primary Purpose

Lymphoma, Multiple Myeloma

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CKD-581

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ASAN Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

CKD-581

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose

Secondary Outcome Measures

Dose Limiting Toxicity

Pharmacokinetics

PK parameters(AUC, Cmax) of CKD-581 & metabolites

Objective response rate

Progression Free survival

Full Information

NCT ID

NCT01580371

First Posted

April 16, 2012

Last Updated

October 4, 2016

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT01580371

Brief Title

Safety and Pharmacokinetic Profile of CKD-581

Acronym

CKD-581

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

CKD-581

Intervention Type

Drug

Intervention Name(s)

CKD-581

Other Intervention Name(s)

Histone Deacetylase Inhibitor

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose

Time Frame

Up to 28 days (For 1st cycle)

Secondary Outcome Measure Information:

Title

Dose Limiting Toxicity

Time Frame

Up to 28 days (For 1st cycle)

Title

Pharmacokinetics

Description

PK parameters(AUC, Cmax) of CKD-581 & metabolites

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)

Title

Objective response rate

Time Frame

every 56 days (every 2 cycle)

Title

Progression Free survival

Time Frame

up to progression

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dok Hyun Yoon, Ph.D

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

ASAN Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Pharmacokinetic Profile of CKD-581

We'll reach out to this number within 24 hrs