Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
19. prosince 2018 aktualizováno: Pfizer
A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG
This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.
Přehled studie
Postavení
Postavení
Dokončeno
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Intervenční
Zápis (Aktuální)
Zápis
119
Fáze
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
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New Territories, Hongkong
- Department of Clinical Oncology, Tuen Mun Hospital
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Shatin, NT, Hongkong
- Prince of Wales Hospital
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NEW Territories
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Tuen Mun, NEW Territories, Hongkong
- Department of Clinical Oncology, Tuen Mun Hospital
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Tuen Mun, NEW Territories, Hongkong
- Department of Clinical Oncology, Tuen Mun Hospital
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Aichi, Japonsko, 464-8681
- Aichi cancer center central hospital Thoracic Oncology
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Tokyo
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Koto-Ku, Tokyo, Japonsko, 135-8550
- The Cancer Institute Hospital of JFCR
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Seoul, Korejská republika, 110-744
- Seoul National University Hospital
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Seoul, Korejská republika, 120-752
- Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
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Seoul, Korejská republika, 135-710
- SamsungMedicalCenter, Sungkyunkwan Univ School of Medicine
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California
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Orange, California, Spojené státy, 92868-3298
- University of California, Irvine
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Orange, California, Spojené státy, 92868
- Chao Family Comprehensive Cancer Center UC Irvine Medical Center
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Pleasant Hill, California, Spojené státy, 94523
- Bay Area Cancer Research Group, LLC
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Salinas, California, Spojené státy, 93901
- Pacific Cancer Care
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San Francisco, California, Spojené státy, 94110
- San Francisco General Hospital
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- University Of Colorado Hospital
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Aurora, Colorado, Spojené státy, 80045
- University of Colorado Clinical Trials Office (CTO)
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Florida
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Fort Myers, Florida, Spojené státy, 33919
- Florida Cancer Specialists
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Maryland
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Bethesda, Maryland, Spojené státy, 20892
- National Institutes of Health National Cancer Institute
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Spojené státy, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Spojené státy, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Spojené státy, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Spojené státy, 02115
- Brigham & Women's Hospital
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Boston, Massachusetts, Spojené státy, 02210
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Spojené státy, 02210
- Dana-Farber Cancer lnstitute
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Missouri
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Springfield, Missouri, Spojené státy, 65804
- St. John's Hospital,
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New York
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New York, New York, Spojené státy, 10022
- Memorial Sloan-Kettering Cancer Center
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Stony Brook, New York, Spojené státy, 11794-9446
- Stony Brook University Medical Center - Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27514
- Investigational Drug Service, Pharmacy Department, UNC Hospitals
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Chapel Hill, North Carolina, Spojené státy, 27599-7600
- UNC Hospitals, The University of North Carolina at Chapel Hill
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Chapel Hill, North Carolina, Spojené státy, 27599-2008
- Division of Hemotology/Oncology
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Durham, North Carolina, Spojené státy, 27710
- Morris Cancer Center
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North Dakota
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Bismarck, North Dakota, Spojené státy, 58501
- Legacy Pharma Research
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Bismarck, North Dakota, Spojené státy, 58501
- Mid Dakota Clinic, P.C
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37404
- Chattanooga Oncology & Hematology Associates, P.C.
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Nashville, Tennessee, Spojené státy, 37203 (Administration)
- Sarah Cannon Research Institute
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Nashville, Tennessee, Spojené státy, 37203(Pharmacy)
- Sarah Cannon Research Institute
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Virginia
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Richmond, Virginia, Spojené státy, 23230
- Virginia Cancer Institute
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Washington
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Seattle, Washington, Spojené státy, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Spojené státy, 98195
- University of Washington Medical Center
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Taipei, Tchaj-wan, 100
- National Taiwan University Hospital
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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
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:
- Advanced adenocarcinoma of lung, measurable disease
- Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
- patients with known EGFR activating mutation regardless of smoking status
- ECOG(Eastern Cooperative Oncology Group) 0-1.
Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy
Exclusion Criteria:
- Active brain metastases
- Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
- known EGFR wild type NSCLC
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: Nerandomizované
- Maskování: Žádné (otevřený štítek)
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
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Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.
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Experimentální: Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
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Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Progression-Free Survival (PFS) at Month 4: Cohort A
Časové okno: Baseline up to Month 4
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PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease [PD] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment.
Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria.
PD = greater than or equal to (>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.
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Baseline up to Month 4
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Progression-Free Survival (PFS) at Month 4: Cohort B
Časové okno: Baseline up to Month 4
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PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as PD or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment.
Documentation of progression was based on RECIST v1.0 criteria.
PD: >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.
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Baseline up to Month 4
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Progression-Free Survival (PFS)
Časové okno: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first.
PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44.
PD: >= 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions.
Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.
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Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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Best Overall Response (BOR)
Časové okno: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0.
Complete Response (CR): disappearance of all lesions.
Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions.
PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions.
Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start.
CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response.
SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks.
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Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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Duration of Response (DR)
Časové okno: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first.
Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44.
DR was calculated for a subgroup of participants with a confirmed objective tumor response.
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Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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Overall Survival (OS)
Časové okno: Randomization until death or last date known to be alive.
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Time in months from the start of study treatment to date of death due to any cause.
OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44.
Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
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Randomization until death or last date known to be alive.
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European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
Časové okno: Baseline (Cycle [C]1 Day 1), up to C75
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EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties).
Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent').
For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms.
Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales.
Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales.
Stable was a mean change from baseline of <10.
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Baseline (Cycle [C]1 Day 1), up to C75
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European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score
Časové okno: Baseline (C1D1) up to C75
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QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week.
The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ).
Response range: (1) not at all to (4) very much.
Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms.
Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain.
Improvement was defined as a mean decrease from baseline of ≤10.
Worsened was defined as a mean increase from baseline of ≥10.
Stable was a mean change from baseline of <10.
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Baseline (C1D1) up to C75
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Trough Plasma Concentrations (Ctrough) of Dacomitinib
Časové okno: Predose on C1D14, C2D1, C3D1, C4D1
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Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment).
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Predose on C1D14, C2D1, C3D1, C4D1
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
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
- Kris MG, Camidge DR, Giaccone G, Hida T, Li BT, O'Connell J, Taylor I, Zhang H, Arcila ME, Goldberg Z, Janne PA. Targeting HER2 aberrations as actionable drivers in lung cancers: phase II trial of the pan-HER tyrosine kinase inhibitor dacomitinib in patients with HER2-mutant or amplified tumors. Ann Oncol. 2015 Jul;26(7):1421-7. doi: 10.1093/annonc/mdv186. Epub 2015 Apr 21.
- Janne PA, Ou SI, Kim DW, Oxnard GR, Martins R, Kris MG, Dunphy F, Nishio M, O'Connell J, Paweletz C, Taylor I, Zhang H, Goldberg Z, Mok T. Dacomitinib as first-line treatment in patients with clinically or molecularly selected advanced non-small-cell lung cancer: a multicentre, open-label, phase 2 trial. Lancet Oncol. 2014 Dec;15(13):1433-1441. doi: 10.1016/S1470-2045(14)70461-9. Epub 2014 Nov 5.
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)
Začátek studia
11. března 2009
Primární dokončení (Aktuální)
Primární dokončení
27. dubna 2012
Dokončení studie (Aktuální)
Dokončení studie
30. dubna 2015
Termíny zápisu do studia
První předloženo
První předloženo
5. ledna 2009
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
6. ledna 2009
První zveřejněno (Odhad)
První zveřejněno
7. ledna 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
8. ledna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. prosince 2018
Naposledy ověřeno
Naposledy ověřeno
1. prosince 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- A7471017
- 2011-002794-39 (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 .