- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00425854
An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
5 december 2013 uppdaterad av: 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Brussel, Belgien
- 1200.10.3208 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgien
- 1200.10.3201 Boehringer Ingelheim Investigational Site
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Charleroi, Belgien
- 1200.10.3203 Boehringer Ingelheim Investigational Site
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Gent, Belgien
- 1200.10.3205 Boehringer Ingelheim Investigational Site
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Leuven, Belgien
- 1200.10.3204 Boehringer Ingelheim Investigational Site
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Wilrijk, Belgien
- 1200.10.3206 Boehringer Ingelheim Investigational Site
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Berlin, Tyskland
- 1200.10.49005 Boehringer Ingelheim Investigational Site
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Düsseldorf, Tyskland
- 1200.10.49007 Boehringer Ingelheim Investigational Site
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Erlangen, Tyskland
- 1200.10.49008 Boehringer Ingelheim Investigational Site
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Essen, Tyskland
- 1200.10.49010 Boehringer Ingelheim Investigational Site
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Kiel, Tyskland
- 1200.10.49003 Boehringer Ingelheim Investigational Site
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Mainz, Tyskland
- 1200.10.49004 Boehringer Ingelheim Investigational Site
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München, Tyskland
- 1200.10.49001 Boehringer Ingelheim Investigational Site
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Wiesbaden, Tyskland
- 1200.10.49006 Boehringer Ingelheim Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: BIBW 2992
high dose once daily
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high dose once daily
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Objective Response (OR)
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Clinical Benefit (CB)
Tidsram: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
|
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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2006
Primärt slutförande (Faktisk)
1 maj 2009
Studieregistreringsdatum
Först inskickad
22 januari 2007
Först inskickad som uppfyllde QC-kriterierna
22 januari 2007
Första postat (Uppskatta)
23 januari 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
31 december 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 december 2013
Senast verifierad
1 augusti 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1200.10
- 2006-002018-36 (EudraCT-nummer: EudraCT)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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-
Boehringer IngelheimAvslutad
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University of ReadingOkänd
-
Boehringer IngelheimAvslutad
-
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-
Boehringer IngelheimAvslutad
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Boehringer IngelheimAvslutad