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A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

26. června 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

132

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

  • Austrálie
    • New South Wales
      • Newcastle, New South Wales, Austrálie, 2298
        • Calvary Mater Newcastle; Melanoma Clinic
      • Westmead, New South Wales, Austrálie, 2145
        • Westmead Hospital; Medical Oncology and Pallative Care
    • Victoria
      • Melbourne, Victoria, Austrálie, 3000
        • Peter Maccallum Cancer Institute; Medical Oncology
  • Spojené státy
    • California
      • Los Angeles, California, Spojené státy, 90095-6984
        • UCLA - School of Medicine; Division of Hematology/Oncology
    • Colorado
      • Denver, Colorado, Spojené státy, 80262
        • University of Colorado
    • Florida
      • Tampa, Florida, Spojené státy, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Spojené státy, 02115
        • Dana Farber Cancer Inst. ; Dept. of Medical Oncology
      • Boston, Massachusetts, Spojené státy, 02114
        • Massachusetts General Hospital;Hematology/ Oncology
    • New York
      • New York, New York, Spojené státy, 10036
        • New York University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19104-4283
        • Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology
      • Pittsburgh, Pennsylvania, Spojené státy, 15213
        • University of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, Spojené státy, 37232
        • Vanderbilt-Ingram Cancer Ctr
    • Texas
      • Dallas, Texas, Spojené státy, 75246
        • Texas Oncology-Baylor Sammons Cancer Center
      • Houston, Texas, Spojené státy, 77030
        • University of Texas M.D. Anderson Cancer Center

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 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

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: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Jednoruč
Lék: vemurafenib
960 mg b.i.d. continuous oral dosing

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hoffmann-La Roche

Publikace a užitečné odkazy

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

Obecné publikace

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)

30. září 2009

Primární dokončení (Aktuální)

27. září 2010

Dokončení studie (Aktuální)

3. června 2014

Termíny zápisu do studia

První předloženo

28. července 2009

První předloženo, které splnilo kritéria kontroly kvality

29. července 2009

První zveřejněno (Odhad)

30. července 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

25. července 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. června 2017

Naposledy ověřeno

1. června 2017

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NP22657

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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