- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Brno, Czechy, 65653
- Masarykuv onkologicky ustav
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Arizona
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Scottsdale, Arizona, Stany Zjednoczone, 85258
- Pinnacle Oncology Hematology
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Tucson, Arizona, Stany Zjednoczone, 85704
- Arizona Oncology Associates, PC - HOPE
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Tucson, Arizona, Stany Zjednoczone, 85710
- Arizona Oncology Associates, PC-Hope
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80012
- Rocky Mountain Cancer Centers
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Boulder, Colorado, Stany Zjednoczone, 80303
- Rocky Mountain Cancer Centers
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Centennial, Colorado, Stany Zjednoczone, 80112
- Rocky Mountain Cancer Centers
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Colorado Springs, Colorado, Stany Zjednoczone, 80907
- Rocky Mountain Cancer Centers
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Colorado Springs, Colorado, Stany Zjednoczone, 80909
- Rocky Mountain Cancer Centers
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Denver, Colorado, Stany Zjednoczone, 80218
- Rocky Mountain Cancer Centers
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Denver, Colorado, Stany Zjednoczone, 80220
- Rocky Mountain Cancer Centers
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Lakewood, Colorado, Stany Zjednoczone, 80228
- Rocky Mountain Cancer Centers
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Littleton, Colorado, Stany Zjednoczone, 80120-4413
- Rocky Mountain Cancer Centers
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Rocky Mountain Cancer Centers
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Longmont, Colorado, Stany Zjednoczone, 80501
- Rocky Mountain Cancer Centers
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Parker, Colorado, Stany Zjednoczone, 80138
- Rocky Mountain Cancer Centers
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Pueblo, Colorado, Stany Zjednoczone, 81008
- Rocky Mountain Cancer Centers
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Thornton, Colorado, Stany Zjednoczone, 80260
- Rocky Mountain Cancer Centers
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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68114
- Nebraska Methodist Hospital
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Nevada
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Henderson, Nevada, Stany Zjednoczone, 89074
- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, Stany Zjednoczone, 89052
- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, Stany Zjednoczone, 89014
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89169
- Comprehensive Cancer Centers of Nevada
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27704
- Regional Cancer Care-Durham
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Texas
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Tyler, Texas, Stany Zjednoczone, 75702
- Texas Oncology-Tyler
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Washington
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Seattle, Washington, Stany Zjednoczone, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Stany Zjednoczone, 98195
- University of Washington Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: ARM B
AG-013736 alone
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5 mg PO BID
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Number of Participants With Non-serious AEs and SAEs
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory według typu histologicznego
- Nowotwory
- Nowotwory urologiczne
- Nowotwory układu moczowo-płciowego
- Nowotwory według lokalizacji
- Choroby nerek
- Choroby Urologiczne
- Rak gruczołowy
- Nowotwory gruczołowe i nabłonkowe
- Nowotwory nerek
- Rak, Komórka Nerki
- Rak
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory enzymów
- Środki przeciwnowotworowe
- Inhibitory kinazy białkowej
- Aksytynib
Inne numery identyfikacyjne badania
- B1131004
- 2011-002190-33 (Numer EudraCT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na PF-04856884
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PfizerZakończony
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PfizerZakończony
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University of FloridaZakończonyObjawy żołądkowo-jelitowe | Częstotliwość stolca | Czas pasażu żołądkowo-jelitowegoStany Zjednoczone
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PfizerZakończony
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PfizerZakończonySchizofreniaStany Zjednoczone
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PfizerZakończony
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PfizerZakończony
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PfizerRekrutacyjnyAtopowe zapalenie skóryStany Zjednoczone, Kanada
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PfizerJeszcze nie rekrutacja