- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00858234
Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098)
7. april 2021 opdateret af: Merck Sharp & Dohme LLC
A Multicenter, Open-Label, Phase I Study of MK-0683 in Combination With Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma
The primary purpose of this clinical study is to determine the recommended clinical doses of vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed and/or refractory multiple myeloma (MM).
It was hypothesized that administration of vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to permit further study in participants with relapsed and/or refractory MM.
Study results are based on data collected up to the data cut-off date of 20-March-2011.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
9
Fase
- Fase 1
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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- is ≥20 years of age.
- has an established diagnosis of MM based on the myeloma diagnostic criteria
- has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen
- has adequate organ function
Exclusion Criteria:
- has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation during the study
- has known hypersensitivity to any components of vorinostat or bortezomib
- has active hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus (HIV) positive
- has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors
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: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Vorinostat + Bortezomib
Participants undergo up to 3 successive 21-day treatment cycles.
During Cycle 1, participants receive vorinostat (400 mg once daily [QD] on Days 1 through 14) + bortezomib (1.3 mg/m^2 intravenous [IV] on Days 1, 4, 8, and 11).
If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11).
If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m^2 IV on Days 1, 4, 8, and 11).
|
Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food.
Andre navne:
Bortezomib (1.0 or 1.3 mg/m^2) intravenous infusion.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Dose-Limiting Toxicity (DLT) During Cycle 1
Tidsramme: Up to 21 days
|
The number of participants with ≥1 DLT during Cycle 1 is reported.
A DLT is defined as an event considered by the investigator to be related to study treatment, and either: 1) a Grade 3 or 4 non-hematologic event (except for manageable toxicity by supportive care or non-prohibited therapies, or a transient increase in alanine aminotransferase [ALT]/aspartate aminotransferase [AST]); or 2) a Grade 4 hematologic toxicity except neutropenia or hemoglobin decreased (neutropenia was a DLT if it was Grade 3-4 with fever ≥38.5°C;
Grade 3-4 with an infection requiring antibiotic/antifungal therapy; or Grade 4 and lasting ≥5 days).
|
Up to 21 days
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With an Adverse Event (AE)
Tidsramme: Up to 346 days (up to 30 days after the final dose of study treatment)
|
The number of participants with ≥1 AE is reported.
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product(s), whether or not considered related to the use of the product(s).
|
Up to 346 days (up to 30 days after the final dose of study treatment)
|
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Vorinostat Administered With Bortezomib on Days 1 and 11
Tidsramme: Predose and 0.8, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 1 and 11
|
The AUC0-24hr of vorinostat in plasma on Days 1 and 11 is reported in participants who also received bortezomib.
|
Predose and 0.8, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 1 and 11
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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)
13. februar 2009
Primær færdiggørelse (Faktiske)
11. juni 2010
Studieafslutning (Faktiske)
19. april 2012
Datoer for studieregistrering
Først indsendt
4. marts 2009
Først indsendt, der opfyldte QC-kriterier
6. marts 2009
Først opslået (Skøn)
9. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. april 2021
Sidst verificeret
1. april 2021
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
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Histon deacetylase hæmmere
- Bortezomib
- Vorinostat
Andre undersøgelses-id-numre
- 0683-098
- MK-0683-098 (Anden identifikator: Merck)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Vorinostat
-
Peter MacCallum Cancer Centre, AustraliaGlaxoSmithKline; Merck Sharp & Dohme LLCAfsluttetFollikulært lymfom | Mantelcellelymfom | Marginal zone lymfomAustralien
-
Merck Sharp & Dohme LLCAfsluttet
-
Groupe Francophone des MyelodysplasiesMerck Sharp & Dohme LLCAfsluttet
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Afsluttet
-
Merck Sharp & Dohme LLCIkke længere tilgængelig
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AfsluttetLymfom | Leukæmi | Tyndtarmskræft | Prostatakræft | Uspecificeret fast tumor hos voksne, protokolspecifik | Myelom og plasmacelle-neoplasmaForenede Stater
-
Virginia Commonwealth UniversityTrukket tilbage
-
National Center for Tumor Diseases, HeidelbergMerck Sharp & Dohme LLC; University Hospital HeidelbergAfsluttet
-
University of CalgaryUkendt
-
Merck Sharp & Dohme LLCAfsluttet