- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00625768
Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
24. august 2009 opdateret af: Antisoma Research
A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
- To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose (MTD) of AS1409 in single and repeated doses.
- To determine biological responses to AS1409, including interferon-γ and IP-10 circulating concentrations.
- To determine preliminary pharmacokinetics of AS1409.
- To determine the immunogenicity of AS1409
- To explore the anti-tumour activity of AS1409.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
13
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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London, Det Forenede Kongerige, W6 8RF
- Charing Cross Hospital
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London, Det Forenede Kongerige, SE1 9RT
- Guys Hospital
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Auckland, New Zealand
- Auckland Medical School
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Hamilton, New Zealand
- Waikato DHB
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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:
- Be 18 years or older at the time of giving informed consent.
- Histologically confirmed diagnosis of renal cell carcinoma or malignant melanoma.
- If renal cell carcinoma, of clear cell or chromophilic/papillary type, with metastases at any site (but excluding patients with single bony lesion only).
- If malignant melanoma, unresectable Stage III disease or Stage IV disease, with metastases at any site (but excluding patients with single bony lesion only)
- Patients with clinically stable CNS metastases may enter who have been treated with surgery or radiation and who do not require steroid therapy.
- ECOG performance status 0-2.
- Patients who have received prior systemic treatment for their malignancy with chemotherapeutic or biological therapies may enter, provided treatment was completed within 4 weeks of study entry.
- Patients who have received prior experimental therapy may enter, provided treatment was completed within 12 weeks of study entry.
- Have adequate bone marrow function as evidenced by neutrophils >1.5 x109/L and platelets >100 x109/L.
- Have adequate liver and kidney function, as shown by serum bilirubin ≤1.5x upper limit of normal for the laboratory; ALT and AST both ≤2x upper limit of normal; and creatinine ≤1.5x upper limit of normal.
- Have either evaluable or measurable disease (patients entering an ascending dosage cohort) or measurable disease (patients entering the study after MTD is defined).
- Patients who have failed and or are ineligible for standard first line therapy (in accordance with individual institutional practice)
Exclusion Criteria:
Patients with any of the following will be excluded from the study:
- Patients at poor medical risk because of non-malignant systemic disease or active infection.
- History of clinically significant autoimmune or predominantly Th1-driven clinical disorders (such as rheumatoid arthritis, psoriasis, chronic inflammatory bowel disease, for example), with the exception of autoimmune endocrinopathies now treated with replacement therapy.
- Diabetic retinopathy.
- Substantive surgery within 4 weeks prior to study entry, or expectation of surgery during the study period.
- Malignancy other than renal cell carcinoma or malignant melanoma within 5 years of study entry, except for non-melanoma skin cancer and cervical intraepithelial neoplasia treated definitively or other cancer from which the patient has been disease-free for 5 years.
- Concurrent treatment with systemic steroids or with other immunosuppressive therapies.
- If female, pregnant or breastfeeding;
- Women of child bearing potential or sexually active males, unless (1) the patient (if female, or the patient's partner, if male) is surgically sterile or (2) using adequate contraception (defined as either IUD, oral or depot contraceptive, or barrier plus spermicide) while receiving study treatment and for at least 6 months after termination of treatment. Women must be post-menopausal for at least 2 years to be considered of non-childbearing potential
- Any concurrent medical or psychological condition that would limit the ability of the patient to provide informed consent or to comply with the obligations of the study.
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)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Tumor assessment
Tidsramme: 6 weeks, response confirmed at 4 weeks
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6 weeks, response confirmed at 4 weeks
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Biomarkers (interferon-γ and IP-10 Interferon)
Tidsramme: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
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Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
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Adverse event monitoring
Tidsramme: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
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Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: James Spicer, MD, Kings College School of Medicine
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. januar 2008
Primær færdiggørelse (Faktiske)
1. april 2009
Studieafslutning (Faktiske)
1. april 2009
Datoer for studieregistrering
Først indsendt
20. februar 2008
Først indsendt, der opfyldte QC-kriterier
27. februar 2008
Først opslået (Skøn)
28. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. august 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2009
Sidst verificeret
1. august 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Nyresygdomme
- Urologiske sygdomme
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Nyre-neoplasmer
- Neuroendokrine tumorer
- Nevi og melanomer
- Karcinom, nyrecelle
- Karcinom
- Melanom
Andre undersøgelses-id-numre
- AS1409-101
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 Metastatisk nyrecellekarcinom
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Association Pour La Recherche des Thérapeutiques...AfsluttetClear Cell Metastatic Renal Cell CarcinomaFrankrig
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Sunnybrook Health Sciences CentrePfizerAfsluttetClear Cell Metastatic Renal Cell CarcinomaCanada