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PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma

19. prosince 2018 aktualizováno: Pfizer

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

To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736) in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Detailní popis

The study was prematurely discontinued on 06Nov2012 due to tolerability findings in patients treated in Part I of the study that have prompted the Sponsor to re-evaluate the strategic development of the program. An unexpected frequency of arterial thrombotic events (ATEs) and venous thrombotic events (VTEs) were reported in patients treated in Part I.

Typ studie

Intervenční

Zápis (Aktuální)

18

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Arizona
      • Scottsdale, Arizona, Spojené státy, 85258
        • Pinnacle Oncology Hematology
      • Tucson, Arizona, Spojené státy, 85704
        • Arizona Oncology Associates, PC - HOPE
      • Tucson, Arizona, Spojené státy, 85710
        • Arizona Oncology Associates, PC-Hope
    • Colorado
      • Aurora, Colorado, Spojené státy, 80012
        • Rocky Mountain Cancer Centers
      • Boulder, Colorado, Spojené státy, 80303
        • Rocky Mountain Cancer Centers
      • Centennial, Colorado, Spojené státy, 80112
        • Rocky Mountain Cancer Centers
      • Colorado Springs, Colorado, Spojené státy, 80907
        • Rocky Mountain Cancer Centers
      • Colorado Springs, Colorado, Spojené státy, 80909
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, Spojené státy, 80218
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, Spojené státy, 80220
        • Rocky Mountain Cancer Centers
      • Lakewood, Colorado, Spojené státy, 80228
        • Rocky Mountain Cancer Centers
      • Littleton, Colorado, Spojené státy, 80120-4413
        • Rocky Mountain Cancer Centers
      • Lone Tree, Colorado, Spojené státy, 80124
        • Rocky Mountain Cancer Centers
      • Longmont, Colorado, Spojené státy, 80501
        • Rocky Mountain Cancer Centers
      • Parker, Colorado, Spojené státy, 80138
        • Rocky Mountain Cancer Centers
      • Pueblo, Colorado, Spojené státy, 81008
        • Rocky Mountain Cancer Centers
      • Thornton, Colorado, Spojené státy, 80260
        • Rocky Mountain Cancer Centers
    • Nebraska
      • Omaha, Nebraska, Spojené státy, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Henderson, Nevada, Spojené státy, 89074
        • Comprehensive Cancer Centers of Nevada
      • Henderson, Nevada, Spojené státy, 89052
        • Comprehensive Cancer Centers of Nevada
      • Henderson, Nevada, Spojené státy, 89014
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Spojené státy, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Spojené státy, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Spojené státy, 89169
        • Comprehensive Cancer Centers of Nevada
    • North Carolina
      • Durham, North Carolina, Spojené státy, 27704
        • Regional Cancer Care-Durham
    • Texas
      • Tyler, Texas, Spojené státy, 75702
        • Texas Oncology-Tyler
    • Washington
      • Seattle, Washington, Spojené státy, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Spojené státy, 98195
        • University of Washington Medical Center
  • Česko
      • Brno, Česko, 65653
        • Masarykuv Onkologicky Ustav

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: ARM A
PF-04856884 in combination with AG-013736
Biologický: PF-04856884
15 mg/kg/week intravenously [IV] until toxicity or disease progression
Lék: Axitinib (AG-013736)
5 mg PO BID
Aktivní komparátor: ARM B
AG-013736 alone
Lék: Axitinib (AG-013736)
5 mg PO BID

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).
Časové okno: 4 months

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
Number of Participants With Serious Adverse Events (SAEs) in Part I
Časové okno: 4 months
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.
4 months
Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II
Časové okno: 3 years
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).
3 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Non-serious AEs and SAEs
Časové okno: 3 years
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).
3 years
Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone.
Časové okno: 4 months
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.
4 months
Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone
Časové okno: 3 years
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).
3 years
Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached)
Časové okno: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods.
Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Cmax (Observed Peak Serum PF-04856884 Concentration)
Časové okno: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods.
Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Cmin (Trough PF-04856884 Serum Concentration)
Časové okno: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods.
Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive
Časové okno: 0 and 360 hours post dose and end of study
Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884.
0 and 360 hours post dose and end of study
Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment
Časové okno: 3 years
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).
3 years
Overall Survival (OS) at 2 Years
Časové okno: 5 years
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.
5 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. listopadu 2011

Primární dokončení (Aktuální)

27. března 2014

Dokončení studie (Aktuální)

27. března 2014

Termíny zápisu do studia

První předloženo

26. srpna 2011

První předloženo, které splnilo kritéria kontroly kvality

23. září 2011

První zveřejněno (Odhad)

27. září 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. ledna 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. prosince 2018

Naposledy ověřeno

1. prosince 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • B1131004
  • 2011-002190-33 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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