- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00051675
Phase I Study of a Monoclonal Antibody for Treatment of Advanced Adenocarcinomas
23. juni 2005 opdateret af: XOMA (US) LLC
An Open-Label, Multi-Dose, Phase I, Dose-Escalating Study of a Subcutaneously Administered Human-Engineered Monoclonal Antibody, ING-1(heMAb), in Subjects With Advanced Adenocarcinomas
The purpose of this study is to evaluate the safety, immunogenicity, and tolerability of a monoclonal antibody administered subcutaneously in the treatment of advanced cancers of the ovary, breast, lung, prostate, colon or rectum that are either refractory to standard therapies or for which therapies that may potentially be of major benefit do not exist.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding
30
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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New York
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Bronx, New York, Forenede Stater, 10461
- Jack D. Weiler Hospital of the Albert Einstein College of Medicine
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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
- Subject has adenocarcinomas of the ovary, breast, lung, prostate, colon or rectum.
- Subject has an advanced metastatic adenocarcinoma that is either refractory to standard therapies or for which therapies that may potentially be of major benefit do not exist.
- Subject has measurable lesions. Subjects with prostate cancer can have non-measurable lesions.
- Subject may have prior radiation therapy if completed at least four weeks prior to study entry, the subject has recovered from the acute toxicities of that therapy, and measurable lesions are in a non-irradiated area.
- Subject may have prior chemotherapy, cytokine therapy or immunotherapy if completed at least four weeks prior to study entry and the subject has recovered from the acute toxicities of that therapy.
- Subjects with tumors responsive to hormone therapy may have prior hormonal therapy if completed at least four weeks prior to study entry. Hormonal therapy for prostate cancer may be continued but must not have been changed less than four weeks prior to study entry.
- Subject has a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Subject has an estimated life expectancy of at least 12 weeks.
- Subject is at least 18 years of age.
Subject has adequate organ function defined as follows:
Hematologic:
- Platelets 100 × 109/L
- Hemoglobin 9.0 g/dL
- Total WBC count 3.5 × 109/L
- PT/INR and PTT are within institutional limits in subjects who are not receiving therapeutic anticoagulation or low dose anticoagulants to maintain venous catheter patency (subjects on anti-coagulant therapy are allowed).
Hepatic:
- Bilirubin 2.0 mg/dL
- Aspartate transaminase (AST) and alanine transaminase (ALT) 3 times the upper limit of normal (AST and ALT 5 times the upper limit of normal is acceptable if liver has tumor involvement and the elevation is due to tumor involvement)
- Renal: Serum creatinine 1.5 mg/dL
- Pancreatic: Amylase and lipase upper limit of the normal (ULN)
- Signed informed consent form.
- Male and female subjects with reproductive potential must use an approved contraceptive method.
- Female subjects with reproductive potential must have a negative serum pregnancy test within seven days of study enrollment.
Exclusion Criteria
- Subject has serious concomitant systemic disorders incompatible with the study.
- Subject has used any other investigational agent within 30 days of study entry.
- Subject is pregnant or lactating.
- Subject has undergone a bone marrow transplant.
- Subject is known to be HIV+ or to have any other recognized immunodeficiency disease. (Note: As the mechanism of action of ING-1(heMAb) is ADCC, subjects need to be immunocompetent).
- Subject has a history of severe allergic or anaphylactic reactions to monoclonal antibodies or antibody fragments. (Note: For subjects who have received prior ING-1(heMAb), the HAHA titer should be negative.)
- Subject has concurrent or prior malignancy, except for adequately-treated basal cell or squamous cell skin cancer, adequately-treated non-invasive carcinomas or other cancer from which the subject has been disease-free for at least two years.
- Subject has an active auto-immune disease requiring chronic treatment.
- Subject is using or has used immunosuppressive drugs such as cyclosporine, ACTH or corticosteroids within four weeks prior to enrollment.
- Subject has brain metastases or a known history of brain metastases.
- Subject has a history of alcoholism or chronic pancreatitis or a family history of acute or chronic pancreatitis.
- Subject has hypertriglyceridemia ( Serum triglycerides 500 mg/dL).
- Subject has a history of gall bladder disease or gallstones (post-cholecystectomy subjects are allowed).
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)
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. juli 2002
Studieafslutning
1. september 2003
Datoer for studieregistrering
Først indsendt
14. januar 2003
Først indsendt, der opfyldte QC-kriterier
15. januar 2003
Først opslået (Skøn)
16. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. juni 2005
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2005
Sidst verificeret
1. september 2004
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INCA104
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 ING-1(heMAb)
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Actuate Therapeutics Inc.Afsluttet
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XenoTherapeutics, Inc.Joseph M. Still Research Foundation, Inc.RekrutteringSårheling | Termisk forbrænding | Forbrændingsgrad anden | Forbrændingsgrad tredje | Forbrænding (lidelse)Forenede Stater
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Hvidovre University HospitalAfsluttet
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Hvidovre University HospitalRekrutteringDeglutition lidelser | Dysfagi, OrofaryngealDanmark
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Actuate Therapeutics Inc.Trukket tilbageAdenoid cystisk karcinom | Spytkirtelneoplasmer | Spytkirtelkræft | SpytkirtelkarcinomForenede Stater
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Glenn J. HannaActuate Therapeutics Inc.Aktiv, ikke rekrutterendeAdenoid cystisk karcinom | Metastatisk kræft | Spytkirtelkræft | Tilbagevendende spytkirtelkræftForenede Stater
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University of California, Los AngelesAfsluttetKvinder med et ENG svangerskabsforebyggende implantatForenede Stater
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Colin D. Weekes, M.D., PhDActuate Therapeutics Inc.; Lustgarten FoundationRekrutteringAdenocarcinom i bugspytkirtlen | Pancreas Adenocarcinom MetastatiskForenede Stater
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Actuate Therapeutics Inc.RekrutteringNeuroblastom | Børnekræft | Diffus Intrinsic Pontine Gliom | Pædiatrisk hjernetumor | Ildfast kræft | Ildfast neoplasma | Refraktær tumor | Kræft Pædiatrisk | Neuroblastom Tilbagevendende | Pædiatrisk lymfom | Pædiatrisk meningiomForenede Stater
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Anwaar SaeedActuate Therapeutics Inc.; Incyte CorporationAktiv, ikke rekrutterendeAdenocarcinom i bugspytkirtlenForenede Stater