Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
17. maj 2012 opdateret af: Pfizer
A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors
To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Chiba
-
Kashiwa, Chiba, Japan
- Pfizer Investigational Site
-
-
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
20 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients histologically or cytologically diagnosed with advanced malignant solid tumors
- Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
Exclusion Criteria:
- Central lung lesions involving major blood vessels
- Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)
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)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Åben
|
AG-013736 5mg twice daily [BID]
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Adverse Events
Tidsramme: Up to 795 days of treatment plus 28-days follow-up
|
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.
|
Up to 795 days of treatment plus 28-days follow-up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax): Single Dose
Tidsramme: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
|
Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
|
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose
Tidsramme: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
|
Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
|
|
|
Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose
Tidsramme: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
|
AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).
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Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
|
|
Terminal Phase Plasma Half-Life (t1/2): Single Dose
Tidsramme: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
|
t1/2 is the time measured for the plasma concentration to decrease by one half.
|
Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
|
|
Maximum Observed Plasma Concentration (Cmax): Multiple Dose
Tidsramme: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
|
Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
|
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose
Tidsramme: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
|
Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
|
|
|
Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose
Tidsramme: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
|
Dosing Interval was 12 hours in this study.
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Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
|
|
Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose
Tidsramme: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
|
Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)
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Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
|
|
Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)
Tidsramme: Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation
|
Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., VEGFR2, s-VEGFR3, s-KIT, and VEGF.
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Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation
|
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The Numbers of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)
Tidsramme: Up to 795 days
|
CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions.
PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions.
CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks.
PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.
|
Up to 795 days
|
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
1. februar 2007
Primær færdiggørelse (Faktiske)
1. august 2009
Studieafslutning (Faktiske)
1. august 2009
Datoer for studieregistrering
Først indsendt
12. marts 2007
Først indsendt, der opfyldte QC-kriterier
12. marts 2007
Først opslået (Skøn)
13. marts 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. maj 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2012
Sidst verificeret
1. maj 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A4061022
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 .