Clinical trial · Interventional
Safety and Pharmacokinetic Profile of CKD-581
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
NCT01580371CI-TRIAL-00024170CKD-581completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CKD-581 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- CKD-581
- interventionNames
- Drug: CKD-581
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- Up to 28 days (For 1st cycle)
Secondary outcomes (4)
- measure
- Dose Limiting Toxicity
- timeFrame
- Up to 28 days (For 1st cycle)
- measure
- Pharmacokinetics
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.