- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03150316
CKD-581 + Lenalidomide + Dexamethasone in Patients With Previously Treated Multiple Myeloma
20. februar 2020 opdateret af: Chong Kun Dang Pharmaceutical
A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Lenalidomide and Dexamethasone in Patients With Previously Treated Multiple Myeloma
This study is to determine the maximum tolerated dose(MTD) and recommened phase 2 dose(RP2D) based on dose limiting toxicity(DLT), and to evaluate safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Lenalidomide and Dexamethasone in patients with Previously Treated Multiple Myeloma.
Studieoversigt
Detaljeret beskrivelse
This is an open label, dose escalation study.
Cohort of 3~6 patients receive escalation doses of CKD-516 until the maximum tolerated dose(MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
18
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Minji Song
- Telefonnummer: 02-3149-7853
- E-mail: songmj@ckdpharm.com
Studiesteder
-
-
Gangnam-gu
-
Seoul, Gangnam-gu, Korea, Republikken, 06351
- Rekruttering
- Samsung Hospital
-
Kontakt:
- Ki Hyun Kim, PI
-
-
Seocho
-
Seoul, Seocho, Korea, Republikken, 06591
- Rekruttering
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Kontakt:
- Chang-ki Min, PI
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- must have received at least two prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2015)
- Eastern Cooperative Oncology Group performance status ≤ 2
- Life expectancy 12 weeks
must have the following laboratory values within 3 weeks prior to first dose of study drug
- absolute neutrophil count(ANC) ≥ 1,500 mm3
- platelet count(PLT)≥ 100,000 mm3
- Hb ≥ 9.0g/dL
- AST(SGOT) and ALT(SGPT) ≤ 3 x upper limit of normal(UNL)
- Serum bilirubin ≤ 1.5 x ULN (but, Gilbert syndrome ≤ 3 x UNL)
- Creatinin Clearance(CrCl) ≤ 50mL/min
One more measureable disease following values
- Serum M-protein ≥ 1g/dL
- Urine M-Protein ≥ 200mg/24hr
- in that case serum M-protein, urine M-Protein nonmeasurable and FLC ratio abnormal, Serum free light chain(FLC) level ≥ 100mg/L(≥10mg/dL)
- more than 24 weeks prior to last lenalidomide dose
- must have signed the consent form
Exclusion Criteria:
- Patients with CNS disease
- Patients with clinically significant heart disease within 24weeks prior to first dose of study drug
- patients with clinically significans abnormal EKG, echocardiography at screening
- patients with patients with embolism within 24 weeks
- patients with active hepatitis, HIV positive(exception, non active hepatitis)
- peripheral neuropathy ≥ CTCAE grade 2 within 2 weeks prior to first dose of study drug
- Patients with clinically significant disease
- Patients with a prior malignancy with in the last 3 years except adequately treated basal cell or squamous cell or skin cancer, in situ cervical cancer
- Patients who have received surgery, chemotherapy, radiation therapy or immunotherapy or any other investigational drugs ≤ 4 weeks prior to first dose of study drug and during treatment period
- Patients who can not anticoagulate
- Patients who have received dexamethasone >10mg/day within 2week prior to first dose of study drug and during treatment period
- Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control. Male patients whose sexual partners are not using effective birth control.
- patients with hypersensitive reaction of lenalidomide or dexamethasone
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treat Regimen
CKD-581(investigational Drug) Lenalidomide Dexamethasone
|
CKD-581(investigational Drug): on days 1, 8, 15 of repeated 28day cycles Lenalidomide: on days 1~21 of repeated 28 day cycles Dexamethasone: administrated once weekly every 28day cycles
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
MTD
Tidsramme: Up to 28 days(for 1st cycle)
|
Maximum Tolerated Dose
|
Up to 28 days(for 1st cycle)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pharmacokinetics(Cmax)
Tidsramme: 1st Cycle day1: up to 24hr
|
Pharmacokinetics
|
1st Cycle day1: up to 24hr
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Objective Response Rate(ORR)
Tidsramme: Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
|
Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
|
Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
|
Progression Free Survival(PFS)
Tidsramme: Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
|
Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
|
Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
|
Overall Survival(OS)
Tidsramme: Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year
|
Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
|
Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year
|
Duration of Response(DOR)
Tidsramme: Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year
|
Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
|
Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year
|
Pharmacokinetics(T1/2)
Tidsramme: 1st Cycle day1: up to 24hr
|
Pharmacokinetics
|
1st Cycle day1: up to 24hr
|
Pharmacokinetics(CL)
Tidsramme: 1st Cycle day1: up to 24hr
|
Pharmacokinetics
|
1st Cycle day1: up to 24hr
|
Pharmacokinetics(AUClast)
Tidsramme: 1st Cycle day1: up to 24hr
|
Pharmacokinetics
|
1st Cycle day1: up to 24hr
|
Pharmacokinetics(AUCinf)
Tidsramme: 1st Cycle day1: up to 24hr
|
Pharmacokinetics
|
1st Cycle day1: up to 24hr
|
Pharmacokinetics(Vd)
Tidsramme: 1st Cycle day1: up to 24hr
|
Pharmacokinetics
|
1st Cycle day1: up to 24hr
|
Pharmacokinetics( MRT)
Tidsramme: 1st Cycle day1: up to 24hr
|
Pharmacokinetics
|
1st Cycle day1: up to 24hr
|
Adverse events
Tidsramme: through study completion, an average of 1 year
|
Adverse events will be assessed using CTCAE criteria.
|
through study completion, an average of 1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Chanki Min, The Catholic University of Korea
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. maj 2017
Primær færdiggørelse (Forventet)
30. juni 2020
Studieafslutning (Forventet)
30. september 2021
Datoer for studieregistrering
Først indsendt
10. maj 2017
Først indsendt, der opfyldte QC-kriterier
10. maj 2017
Først opslået (Faktiske)
12. maj 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hæmatologiske sygdomme
- Hæmoragiske lidelser
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Myelomatose
- Neoplasmer, Plasmacelle
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Immunologiske faktorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Histon deacetylase hæmmere
- Dexamethason
- Lenalidomid
- CKD-581
Andre undersøgelses-id-numre
- 133MM16016
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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