- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00479232
Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1)
A Phase I Clinical Trial of Vorinostat in Combination With Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Patient is at least 18 years old with refractory/relapsed AML
- If untreated AML, patient is older than 60 years old and not a candidate for standard chemotherapy
- Patient is at least 4 weeks from prior treatment and has recovered from all prior treatment side effects
- Patient has no known liver or kidney problems
- Patient knows of no reason they can not receive transfusions of blood clotting cells (platelets)
- Patient is able to swallow capsules
- Patients both male and female are willing to practice birth control during the study
Exclusion Criteria:
- Patient has received prior treatment with valproic acid, decitabine or azacitidine
- Being is less than 18 years of age or if patient has untreated AML is below 60 years of age
- Patient is a women who is pregnant or breastfeeding. Patient has an active infection that requires antibiotics
- Patient has uncontrolled illness including but not limited to the following: heart problems (congestive heart failure, unstable angina pectoris, cardiac arrhythmia), inflammation of the pancreas; a mental or social condition that may interfere with patient following study procedures
- Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy. Patient has a known history of hepatitis B or C infection
- Patient currently has another active cancer other than certain types of skin cancer
- Patient is heterosexual and able to have a child and is unwilling to practice birth control during the study
Studieplan
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: Cohort 1: Vorinostat (sequential)
Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles. Up to 24 months of treatment. Decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment. |
Andre navne:
Andre navne:
|
Eksperimentel: Cohort 2: Vorinostat (concurrent)
Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles. Decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment. |
Andre navne:
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
Tidsramme: Day 1 to 28 of Cycle 1
|
Participants who received at least one dose of vorinostat in combination with decitabine intravenous (IV) at a dose of 20 mg/m^2 daily for 5 days along with oral vorinostat 400 mg once daily for 7 to 14 days in a 28-day cycle concurrently or sequentially, were evaluated to determine the maximum tolerable dose (MTD) determined by the number of participants experiencing dose limiting toxicity (DLT) events defined as any Grade 3 or 4 non-hematological toxicity (reported adverse event) and/or myelosuppression lasting >42 days.
|
Day 1 to 28 of Cycle 1
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Refractory or Relapse Acute Myelogenous Leukemia (AML)
Tidsramme: Approximately 6 months
|
Objective Response Rate was measured in participants with refractory or relapse AML (acute myelogenous leukemia) in combination with Decitabine who were treated with vorinostat and decitabine on either a concurrent or sequential regimen.
The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for Myelodysplastic Syndrome (MDS) participants.
|
Approximately 6 months
|
Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Intermediate-high Risk Myelodysplastic Syndrome (MDS) or Untreated Acute Myelogenous Leukemia (AML)
Tidsramme: Approximately 6 months
|
Objective Response Rate was measured in participants with intermediate-high risk MDS or untreated AML who were treated with vorinostat and decitabine either on a concurrent or sequential regimen.
The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for MDS participants.
|
Approximately 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer efter histologisk type
- Neoplasmer
- Sygdom
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Forstadier til kræft
- Syndrom
- Myelodysplastiske syndromer
- Leukæmi
- Leukæmi, myeloid
- Leukæmi, Myeloid, Akut
- Præleukæmi
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Histon deacetylase hæmmere
- Decitabin
- Vorinostat
Andre undersøgelses-id-numre
- 0683-055
- 2007_500
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 .
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Kliniske forsøg med vorinostat
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Peter MacCallum Cancer Centre, AustraliaGlaxoSmithKline; Merck Sharp & Dohme LLCAfsluttetFollikulært lymfom | Mantelcellelymfom | Marginal zone lymfomAustralien
-
Merck Sharp & Dohme LLCAfsluttet
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Groupe Francophone des MyelodysplasiesMerck Sharp & Dohme LLCAfsluttet
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Afsluttet
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Merck Sharp & Dohme LLCIkke længere tilgængelig
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AfsluttetLymfom | Leukæmi | Tyndtarmskræft | Prostatakræft | Uspecificeret fast tumor hos voksne, protokolspecifik | Myelom og plasmacelle-neoplasmaForenede Stater
-
National Center for Tumor Diseases, HeidelbergMerck Sharp & Dohme LLC; University Hospital HeidelbergAfsluttet
-
Virginia Commonwealth UniversityTrukket tilbage
-
Merck Sharp & Dohme LLCAfsluttet
-
University of CalgaryUkendt