- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00391521
AS703569 Phase I in Patients With Solid Tumours
29. januar 2014 opdateret af: EMD Serono
A Phase I Multicenter, Open-Label, Dose Escalation Trial of AS703569 Given Orally to Subjects With Solid Tumours
This is a Phase I trial.
Some specific protocol information is proprietary and is not publicly available at this time.
Full information will be provided to trial participants.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
104
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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Massachusetts
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Rockland, Massachusetts, Forenede Stater, 02370
- EMD Serono Medical Information Office
-
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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:
- Histopathologically confirmed locally advanced or metastatic solid tumour that is either refractory after standard of care therapy for the disease or for which standard of care therapy is not reliably effective or has a cancer for which no standard therapy exists
- Age greater than or equal to 18 years
- Has read and understands the informed consent form and is willing and able to give informed consent, and subject authorization under Health Insurance Portability and Accountability Act (HIPAA). Fully understands requirements of the study and willing to comply with all study visits and assessments
- Subjects and their partners must be willing to avoid pregnancy during the study and until 1 month after the last study drug administration. Males with female partners of childbearing potential and female subjects of childbearing potential must therefore be willing to use adequate contraception such as, intra uterine device, diaphragm, or condom, for the duration of the study. For the purposes of this study, childbearing potential is defined as: "All female subjects unless they are post- menopausal for at least two years, are surgically sterile or sexually inactive"
- Negative serum pregnancy test at the screening visit for women of childbearing potential
Exclusion Criteria:
- Bone marrow impairment as evidenced by Hb < 9.0 g/dl, ANC < 1.5x 109/L, platelets < 75 x 109/L. Subjects may be transfused.
- Renal impairment as evidenced by serum creatinine > 1.5 x ULN (upper limit of normal), and/or calculated creatinine clearance < 60 ml/min
- Liver function abnormality as defined by total bilirubin > 1.5 ULN, or AST or ALT > 2.5x ULN at screening; for subjects with liver involvement AST or ALT > 5x ULN at screening
- INR (blood coagulation) > 1.5 x ULN for subjects not on therapeutic doses of coumadin
- History of CNS metastases, unless subject has been previously treated for CNS metastases, is stable by CT scan without evidence of cerebral edema, and has no requirements for corticosteroids or anticonvulsants
- History of difficulty swallowing, malabsorption or other chronic gastro- intestinal disease or conditions that may hamper compliance and/or absorption of the tested product
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) > 2
- Known HIV, hepatitis C, or hepatitis B positivity
- Has received chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy or surgical intervention within 28 Days of Day 1 of study drug treatment (6 weeks for nitrosureas or mitomycin C), and must have fully recovered
- Has received extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation
- Has received any investigational agent within 28 days of Day 1
- Has history of any other significant medical disease or intervention including major gastric or small bowel surgery or has a psychiatric condition that might impair the subjects well-being or preclude full participation in the study
- Is a pregnant or nursing female
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: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 1
Regimen 1
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Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle
Andre navne:
Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle
Andre navne:
Regimen 3: 10 mg/m2/day given orally on Days 1, 2, 3 and Days 8, 9, 10 of a 21-day cycle
Andre navne:
|
Aktiv komparator: 2
Regimen 2
|
Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle
Andre navne:
Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle
Andre navne:
Regimen 3: 10 mg/m2/day given orally on Days 1, 2, 3 and Days 8, 9, 10 of a 21-day cycle
Andre navne:
|
Aktiv komparator: 3
Regimen 3
|
Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle
Andre navne:
Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle
Andre navne:
Regimen 3: 10 mg/m2/day given orally on Days 1, 2, 3 and Days 8, 9, 10 of a 21-day cycle
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Number and proportion of subjects experiencing: at least a Dose-Limiting Toxicity (DLT) in each cohort during the first cycle.
Tidsramme: Undefined
|
Undefined
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Plasma and urine PK parameters of AS703569, genetic markers and potential markers of clinical and biological response.
Tidsramme: Undefined
|
Undefined
|
Number and proportion of subjects with Progressive Disease as assessed at the end of every other cycle.
Tidsramme: Undefined
|
Undefined
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Narmyn Rejeb, MD, Merck Serono S.A., Geneva
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. august 2006
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først indsendt
20. oktober 2006
Først indsendt, der opfyldte QC-kriterier
23. oktober 2006
Først opslået (Skøn)
24. oktober 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. januar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. januar 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26865
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 Faste tumorer
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Memorial Sloan Kettering Cancer CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
-
Sorrento Therapeutics, Inc.Trukket tilbageSolid tumor | Recidiverende solid tumor | Refraktær tumor
-
Impact Therapeutics, Inc.RekrutteringSolid tumor | Avanceret solid tumorKina, Taiwan, Forenede Stater, Australien
-
Partner Therapeutics, Inc.Trukket tilbageSolid tumor | Solid tumor, voksenForenede Stater
-
Pyxis Oncology, IncRekrutteringSolid tumor | Avanceret solid tumorForenede Stater, Spanien, Belgien
-
Neurogene Inc.Merck Sharp & Dohme LLCAktiv, ikke rekrutterendeSolid tumor | Avanceret solid tumorForenede Stater, Australien, Canada
-
EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyAfsluttetSolid tumor | Avanceret solid tumorSpanien, Forenede Stater, Holland, Det Forenede Kongerige
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BeiGeneRekrutteringSolid tumor | Avanceret solid tumorForenede Stater, New Zealand, Australien, Kina
Kliniske forsøg med AS703569
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EMD SeronoAfsluttetHæmatologiske maligniteterItalien, Forenede Stater, Schweiz, Belgien, Tyskland
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IBSA Farmaceutici Italia SrlUniversita degli Studi di Catania; Informapro SrlRekruttering