- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00274443
An Open Label Study in Patients With Advanced NSCLC With ABI-007(Abraxane) in Combination With Carboplatin
7. november 2019 opdateret af: Celgene
An Open -Label, Phase II Trial of Increasing Doses of ABI-007 and Carboplatin in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)
This is an open-label dose escalation trial using ABI-007 plus carboplatin.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a multicenter study conducted at study sites in Russia and the Ukraine where various doses of ABI-007 (Abraxane) will be given in combination with carboplatin to patients with non-small cell lung cancer to determine the recommended dose and schedule for this combination therapy for Phase III trials.
The primary objective of this study is to obtain preliminary information on the antitumor activity and adverse events of ABI-007 in combination with carboplatin.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
250
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Saint Petersburg
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St. Petersburg, Saint Petersburg, Den Russiske Føderation
- Study Sites in Russia
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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:
- Histologically or cytologically confirmed NSCLC Stage IIIB with pleural effusion or evidence of inoperable local recurrence or metastasis (Stage IV).
- Male or non-pregnant and non-lactating female, and ≥ 18 years of age. ( )If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β-hCG) documented within 72 hours of the first administration of study drug. ( )If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
- No other current active malignancy.
- Measurable disease
- Patients must have received no prior therapy for the treatment of metastatic disease.
- Patient has the following blood counts at baseline:
( ) ANC ≥ 1.5 x 109/L; ( ) platelets ≥ 100 x 109/L; ( ) Hgb ≥ 9 g/dL.
- Patient has the following blood chemistry levels at baseline:
( ) AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN); ( ) total bilirubin NORMAL; ( ) creatinine ≤ 1.5 mg/dL.
- Expected survival of > 12 weeks.
- ECOG performance status 0 or 1.
- Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
Exclusion Criteria:
- Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable off therapy for at least 1 month.
- The only evidence of metastasis is bone metastases or other nonmeasurable disease.
- Patient has pre-existing peripheral neuropathy of grade 2, 3, or 4.
- Patient received radiotherapy in last 4 weeks, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- Patient has a clinically significant concurrent illness.
- Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study visit.
- Patient has received treatment with any other cytotoxic chemotherapeutic agent or investigational drug within the previous 4 weeks;
- Patient has a history of allergy or hypersensitivity to the study drug.
- Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
- Patient is enrolled in any other clinical protocol or investigational trial.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: ABI-007 and Carboplatin
ABI-007 and Carboplatin in patients with Advanced Non-Small Cell Lung Cancer.
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ABI-007 plus Carboplatin will be administered intravenously over 30 minutes in cycles of 3 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Safety Outcomes: incidence of treatment emergent adverse events.
Tidsramme: Treatment duration
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Treatment duration
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Efficacy Outcomes: percentage of patients who achieve an objective confirmed complete or partial overall antitumor response
Tidsramme: Treatment duration
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Treatment duration
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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)
1. marts 2005
Primær færdiggørelse (Faktiske)
1. juni 2007
Studieafslutning (Faktiske)
1. juni 2007
Datoer for studieregistrering
Først indsendt
10. januar 2006
Først indsendt, der opfyldte QC-kriterier
10. januar 2006
Først opslået (Skøn)
11. januar 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CA028
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 ABI-007 (Abraxane) and Carboplatin
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National Research Council, SpainHospital Universitario 12 de OctubreAfsluttet
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CelgeneTrukket tilbageSolid tumorForenede Stater
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)AfsluttetStadie I ikke-småcellet lungekræft | Stadie II ikke-småcellet lungekræftForenede Stater
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CelgeneAfsluttetKræft i bugspytkirtlenForenede Stater, Canada, Spanien, Australien, Frankrig, Tyskland, Østrig, Italien, Ukraine
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CelgeneAfsluttetMelanom | MetastaserForenede Stater
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Celgene CorporationAfsluttetBrystneoplasmer | Metastaser, NeoplasmaForenede Stater
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Celgene CorporationAfsluttetNeoplasmer | Metastaser, NeoplasmaForenede Stater
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Taiho Pharmaceutical Co., Ltd.Afsluttet
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Celgene CorporationAfsluttetBrystneoplasmer | Metastaser, NeoplasmaForenede Stater
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University Health Network, TorontoCelgene CorporationAfsluttet