An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
5 grudnia 2013 zaktualizowane przez: Boehringer Ingelheim
An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
50
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Brussel, Belgia
- 1200.10.3208 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgia
- 1200.10.3201 Boehringer Ingelheim Investigational Site
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Charleroi, Belgia
- 1200.10.3203 Boehringer Ingelheim Investigational Site
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Gent, Belgia
- 1200.10.3205 Boehringer Ingelheim Investigational Site
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Leuven, Belgia
- 1200.10.3204 Boehringer Ingelheim Investigational Site
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Wilrijk, Belgia
- 1200.10.3206 Boehringer Ingelheim Investigational Site
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Berlin, Niemcy
- 1200.10.49005 Boehringer Ingelheim Investigational Site
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Düsseldorf, Niemcy
- 1200.10.49007 Boehringer Ingelheim Investigational Site
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Erlangen, Niemcy
- 1200.10.49008 Boehringer Ingelheim Investigational Site
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Essen, Niemcy
- 1200.10.49010 Boehringer Ingelheim Investigational Site
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Kiel, Niemcy
- 1200.10.49003 Boehringer Ingelheim Investigational Site
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Mainz, Niemcy
- 1200.10.49004 Boehringer Ingelheim Investigational Site
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München, Niemcy
- 1200.10.49001 Boehringer Ingelheim Investigational Site
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Wiesbaden, Niemcy
- 1200.10.49006 Boehringer Ingelheim Investigational Site
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
Inclusion criteria:
Inclusion Criteria:
- Female patients age 18 years or older
- Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
- HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
- At least one measurable tumour lesion (RECIST);
- Availability of tumour samples
- Written informed consent that is consistent with ICH-GCP guidelines and local law
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.
Exclusion criteria:
Exclusion Criteria:
- Active infectious disease
- Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
- Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
- Active/symptomatic brain metastases
- Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
- ANC less than 1500/mm3 platelet count less than 100 000/mm3
- Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)
- AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
- Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breast-feeding
- Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
- Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
- Active alcohol or drug abuse
- Other malignancy within the past 5 years
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: BIBW 2992
high dose once daily
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high dose once daily
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Objective Response (OR)
Ramy czasowe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST).
OR was primary endpoint only for Cohort B.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Clinical Benefit (CB)
Ramy czasowe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria.
CB was primary endpoint only for Cohort A.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Clinical Benefit (CB)
Ramy czasowe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria.
CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Time to OR
Ramy czasowe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Duration of OR
Ramy czasowe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Progression-free Survival (PFS)
Ramy czasowe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first.
It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment.
Median time results from unstratified Kaplan-Meier estimates.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Overall Survival (OS)
Ramy czasowe: From randomisation to end of follow-up.
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OS is defined as time from randomisation to death.
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From randomisation to end of follow-up.
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Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)
Ramy czasowe: Baseline and last assessment
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LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan.
MUGA scan is an useful noninvasive tool for assessing the function of the heart.
Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.
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Baseline and last assessment
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Best Change From Baseline in ECOG Performance Status
Ramy czasowe: baseline till end of treatment
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Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status.
ECOG is measured as score between 0 (fully active) and 5 (dead).
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baseline till end of treatment
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Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)
Ramy czasowe: day 29
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Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
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day 29
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
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Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 listopada 2006
Zakończenie podstawowe (Rzeczywisty)
1 maja 2009
Daty rejestracji na studia
Pierwszy przesłany
22 stycznia 2007
Pierwszy przesłany, który spełnia kryteria kontroli jakości
22 stycznia 2007
Pierwszy wysłany (Oszacować)
23 stycznia 2007
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
31 grudnia 2013
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
5 grudnia 2013
Ostatnia weryfikacja
1 sierpnia 2013
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1200.10
- 2006-002018-36 (Numer EudraCT: EudraCT)
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 .