Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
5. maj 2015 opdateret af: Merck Sharp & Dohme LLC
Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma
The purposes of this study are:
- To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
- To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
34
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adults with refractory or relapsed multiple myeloma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities)
- Adequate bone marrow reserve
- Adequate hepatic and renal function
- Ability to swallow capsules
- 3 weeks or more since prior chemotherapy and have recovered from prior toxicities
Exclusion Criteria:
- Participants who plan to have a bone marrow transplant within 4 weeks of start of treatment
- Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism
- Participants with other active/uncontrolled clinically significant illness
- Pregnant or nursing female participants
- Participants who received bortezomib within 3 months of start of this trial
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: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: vorinostat 200 mg + bortezomib 0.7 mg/m^2
Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
|
Vorinostat capsules.
Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Andre navne:
Bortezomib injection.
Given twice weekly for 2 weeks with a 1 week break.
Treatment in 21 day cycles.
Andre navne:
|
|
Eksperimentel: vorinostat 200 mg + bortezomib 0.9 mg/m^2
Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
|
Vorinostat capsules.
Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Andre navne:
Bortezomib injection.
Given twice weekly for 2 weeks with a 1 week break.
Treatment in 21 day cycles.
Andre navne:
|
|
Eksperimentel: vorinostat 300 mg + bortezomib 1.3 mg/m^2
Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle.
|
Vorinostat capsules.
Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Andre navne:
Bortezomib injection.
Given twice weekly for 2 weeks with a 1 week break.
Treatment in 21 day cycles.
Andre navne:
|
|
Eksperimentel: vorinostat 400 mg + bortezomib 0.9 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
|
Vorinostat capsules.
Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Andre navne:
Bortezomib injection.
Given twice weekly for 2 weeks with a 1 week break.
Treatment in 21 day cycles.
Andre navne:
|
|
Eksperimentel: vorinostat 400 mg + bortezomib 1.1 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
|
Vorinostat capsules.
Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Andre navne:
Bortezomib injection.
Given twice weekly for 2 weeks with a 1 week break.
Treatment in 21 day cycles.
Andre navne:
|
|
Eksperimentel: vorinostat 400 mg + bortezomib 1.3 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
|
Vorinostat capsules.
Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Andre navne:
Bortezomib injection.
Given twice weekly for 2 weeks with a 1 week break.
Treatment in 21 day cycles.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Duration of Treatment With Vorinostat
Tidsramme: Day 1 to an event causing discontinuation from the study, assessed up to 29 months
|
Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity. Progressive disease was defined as:
biopsy.
Intolerable toxicity was based on the clinical judgment of the investigator. |
Day 1 to an event causing discontinuation from the study, assessed up to 29 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
Tidsramme: Day 1 to disease progression, toxicity, or death, assessed up to 29 months
|
An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
|
Day 1 to disease progression, toxicity, or death, assessed up to 29 months
|
|
Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib
Tidsramme: Day 1 to disease progression, toxicity, or death, assessed up to 29 months
|
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
|
Day 1 to disease progression, toxicity, or death, assessed up to 29 months
|
|
Clinical AE Summary
Tidsramme: Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)
|
An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition. A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose. |
Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)
|
|
Laboratory AE Summary
Tidsramme: Day 1 up to disease progression, toxicity, or death, assessed up to 29 months
|
An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition. A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose. A lab (S)AE was any lab value considered clinically significant in the investigator's judgment. |
Day 1 up to disease progression, toxicity, or death, assessed up to 29 months
|
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
1. september 2005
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. maj 2011
Datoer for studieregistrering
Først indsendt
25. maj 2005
Først indsendt, der opfyldte QC-kriterier
25. maj 2005
Først opslået (Skøn)
26. maj 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. maj 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. maj 2015
Sidst verificeret
1. maj 2015
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
- 0683-015
- 2005_018
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 .