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

19. Dezember 2018 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

18

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: ARM A
PF-04856884 in combination with AG-013736
Biologisch: PF-04856884
15 mg/kg/week intravenously [IV] until toxicity or disease progression
Arzneimittel: Axitinib (AG-013736)
5 mg PO BID
Aktiver Komparator: ARM B
AG-013736 alone
Arzneimittel: Axitinib (AG-013736)
5 mg PO BID

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Non-serious AEs and SAEs
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

21. November 2011

Primärer Abschluss (Tatsächlich)

27. März 2014

Studienabschluss (Tatsächlich)

27. März 2014

Studienanmeldedaten

Zuerst eingereicht

26. August 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. September 2011

Zuerst gepostet (Schätzen)

27. September 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Januar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Dezember 2018

Zuletzt verifiziert

1. Dezember 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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