- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00066885
Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 1/2 Multicenter, Open Label, Dose Ranging Study of DN-101 and Taxotere® in Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Previous Therapy With Platinum-Based Chemotherapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
DN-101 is an oral anti-cancer therapy for solid tumors and various hematologic malignancies. DN-101 is a unique formulation of calcitriol specifically designed for use in cancer. Calcitriol is a naturally occurring hormone and the most potent biologically active form of vitamin D. In high doses, calcitriol is active in many laboratory and animal models of cancer and synergistic with many commonly used chemotherapeutic agents. Until recently, the clinical use of calcitriol as an anti-cancer therapy was limited by hypercalcemia at doses required for anti-tumor activity. Based upon clinical results to date, Novacea believes it has successfully developed a solution to this problem through development of DN-101.
Chemotherapy for NSCLC, while not curative, has been shown to prolong survival in patients with unresectable disease. A number of different chemotherapy agents have been shown to have single-agent activity in NSCLC. These include cisplatin, carboplatin, vinorelbine, gemcitabine, paclitaxel and docetaxel. For first-line therapy of Stage IIIB or Stage IV NSCLC, these agents are generally used in combination. In most cases, first-line chemotherapy consists of a platinum-based agent, either cisplatin or carboplatin, and another chemotherapeutic.
Only one agent, Taxotere®, has been approved in the United States by the Food and Drug Administration for use as second-line chemotherapy in NSCLC.
Undersøgelsestype
Tilmelding
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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California
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Berkeley, California, Forenede Stater, 94704
- Alta Bates Comprehensive Cancer Center
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Vallejo, California, Forenede Stater, 94589
- Kaiser Permanente Medical Center (Northern California)
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Colorado
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Denver, Colorado, Forenede Stater
- Rocky Mountain Cancer Center
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New York
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Albany, New York, Forenede Stater
- New York Oncology Hematology, P.C. - Albany Regional Cancer Center
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater
- Piedmont Hematology Oncology Associates, PLLC
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater
- Cancer Care Associates
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Oregon
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Portland, Oregon, Forenede Stater, 97227
- Kaiser Permanente Northwest
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South Carolina
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Greenville, South Carolina, Forenede Stater
- Cancer Centers of the Carolinas
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
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Vancouver, Washington, Forenede Stater
- Northwest Cancer Specialists, P.C.
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Yakima, Washington, Forenede Stater, 98902
- Yakima Regional Cancer Care Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histopathologically or cytologically proven non-small cell carcinoma of the lung (NSCLC), either Stage IIIB or Stage IV, that has progressed on or after first or second-line chemotherapy
- Measurable disease by RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status < 1
- Life expectancy > 3 months
- Age > 18 years
- Agrees to use adequate contraception throughout the treatment period and for at least 6 months following treatment
- Able to give informed patient consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Howard West, M.D., Swedish Cancer Institute
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
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
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Mikronæringsstoffer
- Membrantransportmodulatorer
- Vitaminer
- Knogletæthedsbevarende midler
- Calciumregulerende hormoner og midler
- Vasokonstriktormidler
- Calciumkanalagonister
- Docetaxel
- Calcitriol
Andre undersøgelses-id-numre
- DN101-004
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 Karcinom, ikke-småcellet lunge
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AHS Cancer Control AlbertaCross Cancer InstituteAfsluttetOmfattende Stage Small Cel Lung CancerCanada
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Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
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National Cancer Institute (NCI)AfsluttetIldfast malignt fast neoplasma | Tilbagevendende malignt fast neoplasma | Metastatisk malignt fast neoplasma | Uoprettelig fast neoplasma | Tilbagevendende småcellet lungekarcinom | Stadie IIIA Lunge småcellet karcinom AJCC v7 | Stadie IIIB Lunge småcellet karcinom AJCC v7 | Stadie IV lunge småcellet... og andre forholdForenede Stater
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeSezary syndrom | Refraktær T-celle non-Hodgkin lymfom | Merkel cellekarcinom | Anaplastisk storcellet lymfom, ALK-positivt | Ekstramammær Paget sygdom | Tilbagevendende T-celle non-Hodgkin lymfom | Tilbagevendende moden T-celle og NK-celle non-Hodgkin lymfom | Refraktær moden T-celle og NK-celle non-Hodgkin... og andre forholdForenede Stater
Kliniske forsøg med calcitriol + docetaxel
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NovaceaAventis PharmaceuticalsUkendtProstatakræftCanada, Forenede Stater
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NovaceaAfsluttetProstatakræftForenede Stater, Canada, Tyskland, Rumænien, Tjekkiet, Tidligere Serbien og Montenegro, Ungarn, Puerto Rico, Slovakiet
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OHSU Knight Cancer InstituteSanofiAfsluttetKræft i bugspytkirtlenForenede Stater
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Rockefeller UniversityAfsluttetAdenocarcinom | Kolorektale polypper | Kolorektalt adenomForenede Stater
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ShireAfsluttet
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyAfsluttetProstatakræft | Præcancerøs/ikke-malign tilstandForenede Stater
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OHSU Knight Cancer InstituteAfsluttetCalcitriol til behandling af patienter med et stigende PSA-niveau efter behandling for prostatakræftProstatakræftForenede Stater
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Atlanta VA Medical CenterEmory UniversityAfsluttetRheumatoid arthritis | Crohns sygdomForenede Stater
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)AfsluttetTobaksbrugsforstyrrelse | Lungekræft | Precancerøs tilstandForenede Stater
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AfsluttetProstatakræftForenede Stater