- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01441414
PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
A PHASE II TRIAL OF PF-04856884 (CVX-060), A SELECTIVE ANGIOPOIETIN-2 (ANG-2) INHIBITOR IN COMBINATION WITH AG-013736 (AXITINIB) IN PATIENTS WITH PREVIOUSLY TREATED METASTATIC RENAL CELL CARCINOMA
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Brno, Cechia, 65653
- Masarykuv onkologicky ustav
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85258
- Pinnacle Oncology Hematology
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Tucson, Arizona, Stati Uniti, 85704
- Arizona Oncology Associates, PC - HOPE
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Tucson, Arizona, Stati Uniti, 85710
- Arizona Oncology Associates, PC-Hope
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Colorado
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Aurora, Colorado, Stati Uniti, 80012
- Rocky Mountain Cancer Centers
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Boulder, Colorado, Stati Uniti, 80303
- Rocky Mountain Cancer Centers
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Centennial, Colorado, Stati Uniti, 80112
- Rocky Mountain Cancer Centers
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Colorado Springs, Colorado, Stati Uniti, 80907
- Rocky Mountain Cancer Centers
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Colorado Springs, Colorado, Stati Uniti, 80909
- Rocky Mountain Cancer Centers
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Denver, Colorado, Stati Uniti, 80218
- Rocky Mountain Cancer Centers
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Denver, Colorado, Stati Uniti, 80220
- Rocky Mountain Cancer Centers
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Lakewood, Colorado, Stati Uniti, 80228
- Rocky Mountain Cancer Centers
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Littleton, Colorado, Stati Uniti, 80120-4413
- Rocky Mountain Cancer Centers
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Lone Tree, Colorado, Stati Uniti, 80124
- Rocky Mountain Cancer Centers
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Longmont, Colorado, Stati Uniti, 80501
- Rocky Mountain Cancer Centers
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Parker, Colorado, Stati Uniti, 80138
- Rocky Mountain Cancer Centers
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Pueblo, Colorado, Stati Uniti, 81008
- Rocky Mountain Cancer Centers
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Thornton, Colorado, Stati Uniti, 80260
- Rocky Mountain Cancer Centers
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68114
- Nebraska Methodist Hospital
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Nevada
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Henderson, Nevada, Stati Uniti, 89074
- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, Stati Uniti, 89052
- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, Stati Uniti, 89014
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Stati Uniti, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Stati Uniti, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Stati Uniti, 89169
- Comprehensive Cancer Centers of Nevada
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North Carolina
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Durham, North Carolina, Stati Uniti, 27704
- Regional Cancer Care-Durham
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Texas
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Tyler, Texas, Stati Uniti, 75702
- Texas Oncology-Tyler
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Washington
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Seattle, Washington, Stati Uniti, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Stati Uniti, 98195
- University of Washington Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Adult male or female patients with histologically or cytologically confirmed renal cell cancer (RCC) with a component of clear cell subtype and evidence of metastasis
- Evidence of unidimensionally measurable disease
- Prior therapy: Part I: Having received 1 to 3 prior systemic regimens for treatment of mRCC
- Part II: Evidence of disease progression following 1 prior regimen administered as 1st line therapy for mRCC. The prior regimen must have contained one of the following: VEGFR2 tyrosine kinase inhibitor (TKI) or other anti VEGF [Vascular Endothelial Growth Factor] compounds, such as bevacizumab
- adequate bone marrow, liver and renal function
Exclusion Criteria:
Part I:
- Intolerant to prior AG 013736 therapy or prior treatment with compounds which contain the core platform antibody as PF 04856884
Part II:
- Prior AG 013736 therapy, more than one systemic first-line regimen for the treatment of mRCC and prior treatment with compounds which contain the core platform antibody as PF 04856884
- major surgery <4 weeks or radiation therapy <2 weeks prior to start of therapy
- clinically significant gastrointestinal abnormalities
- current use or anticipated need for drugs that are known potent CYP3A4 inhibitors and drugs that are known CYP3A4 or CYP1A2 inducers
- history of bleeding diathesis or coagulopathy
- Grade 3 or greater hemorrhage from any cause <4 weeks prior to screening;
- hemoptysis >½ teaspoon of blood per day within 2 weeks prior to screening.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: ARM A
PF-04856884 in combination with AG-013736
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15 mg/kg/week intravenously [IV] until toxicity or disease progression
5 mg PO BID
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Comparatore attivo: ARM B
AG-013736 alone
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5 mg PO BID
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).
Lasso di tempo: 4 months
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Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
4 months
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Number of Participants With Serious Adverse Events (SAEs) in Part I
Lasso di tempo: 4 months
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Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades.
Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily.
Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE.
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4 months
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Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II
Lasso di tempo: 3 years
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PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first.
Progression free survival was to be calculated as (first event date - the date of randomization +1).
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3 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Participants With Non-serious AEs and SAEs
Lasso di tempo: 3 years
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Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades.
Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily.
Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
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3 years
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Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone.
Lasso di tempo: 4 months
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ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set.
Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response.
Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR.
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4 months
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Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone
Lasso di tempo: 3 years
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DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer.
Duration of tumor response was to be calculated as (the end date for DR - first CR or PR that is subsequently confirmed +1).
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3 years
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Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached)
Lasso di tempo: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods.
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Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Cmax (Observed Peak Serum PF-04856884 Concentration)
Lasso di tempo: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods.
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Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Cmin (Trough PF-04856884 Serum Concentration)
Lasso di tempo: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods.
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Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive
Lasso di tempo: 0 and 360 hours post dose and end of study
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Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884.
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0 and 360 hours post dose and end of study
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Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment
Lasso di tempo: 3 years
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PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first.
PFS was to be calculated as (first event date - the date of randomization +1).
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3 years
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Overall Survival (OS) at 2 Years
Lasso di tempo: 5 years
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OS is defined as the time from the first dose date to date of death.
For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier.
The 2-year OS rate will be estimated from a time-to event analysis of OS.
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5 years
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urologiche
- Neoplasie urogenitali
- Neoplasie per sede
- Malattie renali
- Malattie urologiche
- Adenocarcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie renali
- Carcinoma, cellule renali
- Carcinoma
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Axitinib
Altri numeri di identificazione dello studio
- B1131004
- 2011-002190-33 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Carcinoma a cellule renali metastatico
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National Cancer Institute (NCI)NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group BCompletatoCarcinoma a cellule renali a cellule chiare | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti, Canada, Porto Rico
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National Cancer Institute (NCI)TerminatoCarcinoma a cellule renali a cellule chiare | Carcinoma a cellule renali metastatico | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio IV AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti
Prove cliniche su PF-04856884
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PfizerCompletato
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PfizerCompletato
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University of FloridaCompletatoSintomi gastrointestinali | Frequenza delle feci | Tempo di transito gastrointestinaleStati Uniti
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PfizerCompletato
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PfizerCompletato
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PfizerCompletato
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PfizerNon ancora reclutamento