- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01428427
Combination Study of GSK1120212 With Gemcitabine in Subjects With Solid Tumors
8. november 2017 opdateret af: GlaxoSmithKline
A Phase IB Combination Study of MEK Inhibitor GSK1120212 With Gemcitabine in Subjects With Solid Tumors
MEK112111 is a dose-escalation, Phase IB, open-label, single-arm, multi-center study.
The primary objective of the study is to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 dosed in combination with gemcitabine in subjects with solid tumors.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Subjects will be enrolled using a dose-escalation procedure in which the initial cohort receives a fraction of the GSK1120212 dose that achieved a dose limiting toxicity in a previous study and the recommended dose of gemcitabine.
Escalation will proceed until the maximum tolerated doses are identified.
These doses will be selected based on emerging safety data.
Confirmation of the tolerability of the Recommended Phase II Dose (RP2D) will be explored in approximately 12 subjects.
Subjects will continue on treatment until treatment discontinuation criteria are met (disease progression, intercurrent illness, adverse event or consent withdrawal).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
31
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- GSK Investigational Site
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Texas
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San Antonio, Texas, Forenede Stater, 78229
- GSK Investigational Site
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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:
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Age 18 years old or older and able to swallow oral medication.
- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology (ECOG) scale.
- Histologically or cytologically confirmed diagnosis of a solid tumor malignancy that is either relapsed or refractory, or potentially responsive to gemcitabine.
- Tumor Type criteria as listed in protocol.
- Male subjects must agree to use one of the contraception methods listed in protocol.
- A female subject is eligible to participate if she is of non-childbearing potential as defined in the protocol or postmenopausal as defined in the protocol. If of child-bearing potential, she agrees to use protocol specified contraceptive methods
- Adequate organ system function as defined below in the protocol.
Exclusion Criteria:
- Chemotherapy, radiotherapy, or immunotherapy within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of GSK1120212.
- Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter preceding the first dose of GSK1120212 - as long as a minimum of 14 days has passed between the last dose of the prior investigational anti-cancer drug and the first dose of GSK1120212.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug, dimethy sulfoxide (DMSO), or excipients (See protocol)
- Use of a prohibited medication (as defined in protocol) or current use of anticoagulants (e.g. warfarin, heparin, low molecular weight heparin) at therapeutic levels. Low dose (prophylactic) anticoagulants are permitted provided that subject's prothrombin time (PT) and partial thromboplastin time (PTT) meet entry criteria.
- Gastrointestinal disease predicted to interfere with absorption of an oral drug.
- History of retinal vein occlusion (RVO) or central serous retinopathy.
- Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for retinal vein thrombosis.
- Glaucoma diagnosed within one month prior to study day 1.
- Intraocular pressure > 21mm Hg as measured by tonography.
- Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Subjects previously treated for these conditions that are asymptomatic and off corticosteroids for at least two months are permitted. Subjects are not permitted to receive enzyme inducing anti-epileptic drugs (EIAEDs).
- Unresolved toxicity greater than common terminology criteria for adverse events (CTCAE v4.0) grade 1 from previous anti-cancer therapy.
- History of acute coronary within the past 24 weeks.
- QTc interval greater than or equal to 480 mili seconds (msecs).
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Pregnant or lactating female.
- History of hepatitis B or C. NOTE: Subjects with evidence of cleared hepatitis B infection are permitted [Hepatitis B Surface Antigen (HBsAg) negative, anti-HBsAg positive and anti Hepatitis B core antigen (HBc) positive.]
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: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Cohort
Dose escalation to maximum tolerated dose of GSK1120212 and Gemcitabine.
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Continuous daily oral dosing while on study or disease progression (cycle = 28 days).
Dosing once weekly for 3 weeks in a 28 day cycle until disease progression.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Adverse events (AEs) and changes in laboratory values and vital signs.
Tidsramme: From date of randomization until withdrawal from the study due to disease progression, AE, withdrawal of consent or study closure approximately 6 months after last subject was randomized.
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From date of randomization until withdrawal from the study due to disease progression, AE, withdrawal of consent or study closure approximately 6 months after last subject was randomized.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Tumor response as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v 1.1
Tidsramme: At screening and every 8 weeks until withdrawal from the study due to disease progression, AE, withdrawal of consent or study closure approximately 6 months after last subject was randomized.
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At screening and every 8 weeks until withdrawal from the study due to disease progression, AE, withdrawal of consent or study closure approximately 6 months after last subject was randomized.
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drug levels in blood
Tidsramme: first 15 days on study
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first 15 days on study
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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)
12. august 2009
Primær færdiggørelse (Faktiske)
18. juli 2011
Studieafslutning (Faktiske)
18. juli 2011
Datoer for studieregistrering
Først indsendt
10. december 2009
Først indsendt, der opfyldte QC-kriterier
1. september 2011
Først opslået (Skøn)
5. september 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. november 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. november 2017
Sidst verificeret
1. november 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Leukæmi
- Leukæmi, myeloid
- Leukæmi, Myeloid, Akut
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Proteinkinasehæmmere
- Gemcitabin
- Trametinib
Andre undersøgelses-id-numre
- 112111
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 GSK1120212
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Novartis PharmaceuticalsAfsluttetKræftFrankrig, Forenede Stater, Holland, Canada, Taiwan, Korea, Republikken
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Jonsson Comprehensive Cancer CenterNovartis; Stand Up To Cancer; Prostate Cancer FoundationAktiv, ikke rekrutterendeMetastatisk prostatakarcinom | Tilbagevendende prostatakarcinom | Stadie IV prostatakræft | Hormon-resistent prostatakræftForenede Stater
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeAvanceret malignt fast neoplasma | Metastatisk malignt fast neoplasma | Metastatisk malign neoplasma i leveren | Uoprettelig fast neoplasmaForenede Stater, Canada
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National Cancer Institute (NCI)Children's Oncology GroupAktiv, ikke rekrutterendeJuvenil myelomonocytisk leukæmi | Neurofibromatose type 1Forenede Stater
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National Cancer Institute (NCI)AfsluttetLokalt avanceret epithelioid hæmangioendotheliom | Metastatisk epithelioid hæmangioendotheliom | Uoperabelt epithelioid hæmangioendotheliomForenede Stater
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National Cancer Institute (NCI)AfsluttetRefraktært plasmacellemyelom | Tilbagevendende plasmacellemyelomCanada
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater, Frankrig, Det Forenede Kongerige
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National Cancer Institute (NCI)AfsluttetTilbagevendende akut myeloid leukæmi hos voksne | Ubehandlet akut myeloid leukæmi hos voksneForenede Stater
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National Cancer Institute (NCI)GlaxoSmithKlineAfsluttetStadie IV brystkræft | Tilbagevendende brystkarcinom | Invasivt brystkarcinom | Østrogenreceptor negativ | HER2/Neu negativ | Progesteronreceptor negativ | Triple-negativt brystkarcinomForenede Stater
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National Cancer Institute (NCI)NRG OncologyAfsluttetEndometrie clear cell adenocarcinoma | Endometrie blandet cellet adenokarcinom | Endometrial serøst adenokarcinom | Endometrielt udifferentieret karcinom | Endometrial Adenocarcinom | Tilbagevendende livmoderkræftForenede Stater