NCT01580371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1 lymphoma

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

April 16, 2012

Last Update Submit

October 4, 2016

Conditions

LymphomaMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    Up to 28 days (For 1st cycle)

Secondary Outcomes (4)

  • Dose Limiting Toxicity

    Up to 28 days (For 1st cycle)

  • Pharmacokinetics

    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)

  • Objective response rate

    every 56 days (every 2 cycle)

  • Progression Free survival

    up to progression

Study Arms (1)

Treatment

EXPERIMENTAL

CKD-581

Drug: CKD-581

Interventions

CKD-581DRUG

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

Also known as: Histone Deacetylase Inhibitor
Treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASAN Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

LymphomaMultiple Myeloma

Interventions

CKD-581Histone Deacetylase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Dok Hyun Yoon, Ph.D

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 19, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)