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A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

26. Juni 2017 aktualisiert von: Hoffmann-La Roche

An Open-label Multicenter Study on the Efficacy of Continuous Oral Dosing of Vemurafenib on Tumour Response in Previously Treated Patients With Metastatic Melanoma

This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib [RG7204; PLEXXIKON: PLX4032] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is <100 patients.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

132

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

  • Australien
    • New South Wales
      • Newcastle, New South Wales, Australien, 2298
        • Calvary Mater Newcastle; Melanoma Clinic
      • Westmead, New South Wales, Australien, 2145
        • Westmead Hospital; Medical Oncology and Pallative Care
    • Victoria
      • Melbourne, Victoria, Australien, 3000
        • Peter Maccallum Cancer Institute; Medical Oncology
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90095-6984
        • UCLA - School of Medicine; Division of Hematology/Oncology
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80262
        • University of Colorado
    • Florida
      • Tampa, Florida, Vereinigte Staaten, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Vereinigte Staaten, 02115
        • Dana Farber Cancer Inst. ; Dept. of Medical Oncology
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • Massachusetts General Hospital;Hematology/ Oncology
    • New York
      • New York, New York, Vereinigte Staaten, 10036
        • New York University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104-4283
        • Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • University of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37232
        • Vanderbilt-Ingram Cancer Ctr
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75246
        • Texas Oncology-Baylor Sammons Cancer Center
      • Houston, Texas, Vereinigte Staaten, 77030
        • University of Texas M.D. Anderson Cancer 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 patients >/=18 years of age
  • histologically confirmed metastatic melanoma (Stage IV, AJCC)
  • patients must have completed and failed at least one prior standard of care regimen (e.g. DTIC, temozolomide, etc.)
  • BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)
  • measurable disease by RECIST criteria
  • negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion

Exclusion Criteria:

  • active CNS metastases on CT/MRI within 28 days prior to enrollment
  • history of or known carcinomatous meningitis
  • previous treatment with BRAF (sorafenib allowed) or MEK inhibitor
  • cardiac dysrhythmias >2 NCI CTCAE or treatment with drugs with dysrhythmic potential
  • uncontrolled hypertension(>150/100mmHg) despite optimal medical therapy
  • infectious disease including HIV, HBV and HCV

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Einarmig
Arzneimittel: vemurafenib
960 mg b.i.d. continuous oral dosing

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Zeitfenster: From first treatment through September 27, 2010
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
From first treatment through September 27, 2010

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Zeitfenster: From first treatment through September 27, 2010
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
From first treatment through September 27, 2010
Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Zeitfenster: From first treatment through September 27, 2010
Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.
From first treatment through September 27, 2010
Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Zeitfenster: From first treatment through September 27, 2010
Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.
From first treatment through September 27, 2010
Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Zeitfenster: From first treatment through September 27, 2010
PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.
From first treatment through September 27, 2010
Overall Survival
Zeitfenster: From first treatment through September 27, 2010
Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.
From first treatment through September 27, 2010
Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline
Zeitfenster: From first treatment through September 27, 2010
Three parameters were measured. (1) Improvement in the Physician's Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value < 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.
From first treatment through September 27, 2010
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1
Zeitfenster: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).
Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1
Zeitfenster: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.
Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Vemurafenib Plasma Levels at Various Treatment Cycles
Zeitfenster: Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.
Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1
Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)
Zeitfenster: Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1
Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)^β (β=mean [calculated separately for males and females] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.
Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1
Percentage of Patients With Adverse Event
Zeitfenster: From first treatment through September 27, 2010
The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).
From first treatment through September 27, 2010

Mitarbeiter und Ermittler

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

Sponsor

Hoffmann-La Roche

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.

Allgemeine Veröffentlichungen

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)

30. September 2009

Primärer Abschluss (Tatsächlich)

27. September 2010

Studienabschluss (Tatsächlich)

3. Juni 2014

Studienanmeldedaten

Zuerst eingereicht

28. Juli 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juli 2009

Zuerst gepostet (Schätzen)

30. Juli 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. Juli 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2017

Zuletzt verifiziert

1. Juni 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NP22657

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