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Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

27 maj 2017 uppdaterad av: GlaxoSmithKline

A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination With Paclitaxel as Neoadjuvant Therapy in Patients With Newly Diagnosed Inflammatory Breast Cancer

This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

49

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
    • New South Wales
      • Campbelltown, New South Wales, Australien, 2560
        • GSK Investigational Site
      • Liverpool, New South Wales, Australien, 2170
        • GSK Investigational Site
      • Randwick, New South Wales, Australien, 2031
        • GSK Investigational Site
    • Queensland
      • South Brisbane, Queensland, Australien, 4101
        • GSK Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australien, 5042
        • GSK Investigational Site
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • GSK Investigational Site
      • Ringwood East, Victoria, Australien, 3128
        • GSK Investigational Site
  • Frankrike
      • Bayonne, Frankrike, 64100
        • GSK Investigational Site
      • Lille Cedex, Frankrike, 59020
        • GSK Investigational Site
      • Paris cedex 13, Frankrike, 75651
        • GSK Investigational Site
  • Förenta staterna
    • Florida
      • Miami, Florida, Förenta staterna, 33136
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
        • GSK Investigational Site
      • Zion, Illinois, Förenta staterna, 60099
        • GSK Investigational Site
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • GSK Investigational Site
  • Israel
      • Ramat Gan, Israel, 52621
        • GSK Investigational Site
  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M4N 3M5
        • GSK Investigational Site
  • Nya Zeeland
      • Auckland, Nya Zeeland
        • GSK Investigational Site
  • Spanien
      • Barcelona, Spanien, 08035
        • GSK Investigational Site
      • Girona, Spanien, 17007
        • GSK Investigational Site
      • Valencia, Spanien, 46010
        • GSK Investigational Site
  • Storbritannien
      • London, Storbritannien, SW3 6JJ
        • GSK Investigational Site
  • Tunisien
      • Sfax, Tunisien, 3000
        • GSK Investigational Site
      • Sfax, Tunisien, 3029
        • GSK Investigational Site
      • Tunis, Tunisien, 1007
        • GSK Investigational Site
      • Tunis, Tunisien, 1004
        • GSK Investigational Site

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

Allt

Beskrivning

Inclusion criteria:

  • Tumor accessible for multiple biopsies
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • Adequate bone marrow
  • Renal and hepatic function
  • LVEF (left ventricular ejection fraction) greater than 0% based on ECHO (echocardiogram) or MUGA (multigated acquisition).

Exclusion criteria:

  • Females who are pregnant or nursing.
  • Any unstable, pre-existing major medical condition.
  • Received an investigational drug within the past 4 weeks.
  • Had major surgery in the past 2 weeks.
  • Currently receiving amiodarone or has received amiodarone in the past 6 months.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Overall study
A Single arm study with 2 cohorts of participants. Cohort A consists of participants with tumors overexpressing HER2 and/or EGFR. Cohort B consists of participants with tumors expressing EGFR without overexpressing HER2.
Läkemedel: Lapatinib
Daily-monotherapy [1500 milligrams (mg)] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
Läkemedel: Paclitaxel
Weekly (80mg/m^2) combination therapy (with daily Lapatinib) for 12 weeks
Andra namn:
  • Lapatinib

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of participants with pathologic complete response rate (pCR)
Tidsram: Week 12
pCR was defined as the percentage of participants who achieved an assessment of complete response (CR) following pathologic review of resected tissue. CR was the disappearance of all target lesions. Participants in each cohort with unknown or missing response (i.e., those that did not undergo surgery) were included in the denominator when calculating the percentage. From an efficacy standpoint, the HER2+ population response was considered to be of special interest.
Week 12

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of participants with pCR that underwent surgical resection
Tidsram: Week 12
pCR for participants that underwent surgical (surg) resection was defined as the percentage of participants within each cohort who achieved an assessment of CR following pathologic review of resected tissue. CR was the disappearance of all target lesions. Participants in each cohort that did not undergo surgical resection were excluded from the denominator when calculating the percentage. From an efficacy standpoint, the HER2+ population response was considered to be of special interest.
Week 12
Percentage of participants with objective response rate (ORR) at the end of study (Response evaluation criteria in solid tumor [RECIST])
Tidsram: Week 14
ORR at the end of the study was defined as the number of participants within each cohort who had a confirmed CR or partial response (PR) at the end of the study divided by the total number of participants enrolled in each cohort. CR was the disappearance of all target lesions. PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter. Each participant's response was based on the investigator assessment of best response using RECIST criteria. Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage. From an efficacy standpoint, the HER2+ population was considered to be of special interest.
Week 14
Percentage of participants with ORR at the end of study (Clinically Evaluable Skin Disease Criteria)
Tidsram: Week 14
ORR at the end of the study was defined as the number of participants within each cohort who had a confirmed CR or PR at the end of the study divided by the total number of participants enrolled in each cohort. CR was the disappearance of all target lesions. PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter. Each participant's response was based on the investigator assessment of best response using Clinically Evaluable Skin Disease Criteria. Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage. From an efficacy standpoint, HER2+ population was considered to be of special interest.
Week 14
Percentage of participants with ORR at the end of study ('Best' of RECIST and Clinically Evaluable Skin Disease Criteria)
Tidsram: Week 14
ORR at the end of the study was defined as the number of participants within each cohort who had a confirmed CR or PR at the end of the study divided by the total number of participants enrolled in each cohort. CR was the disappearance of all target lesions. PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter. The best response of the participant was defined by the 'Best' combined response (RECIST and Clinically Evaluable Skin Disease Criteria) provided there is no evidence of disease progression. Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage. From an efficacy standpoint, the HER2+ population was considered to be special interest.
Week 14
Percentage of participants with investigator-Assessed Best Response at the end of monotherapy phase (Day 14) (Clinically Evaluable Skin Disease Criteria)
Tidsram: Day 14
ORR at the end of the monotherapy phase was defined as the percentage of participants within each cohort who had a confirmed CR or PR at the end of lapatinib monotherapy (Day 14) divided by the total number of participants enrolled in each cohort. CR was the disappearance of all target lesions. PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter. Each participant's response was based on the investigator assessment of best response using clinically evaluable skin disease criteria. Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage. From an efficacy standpoint, the HER2+ population was considered to be special interest.
Day 14
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Tidsram: Up to Week 14, surgical resection and post treatment
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect, resulted in deterioration in left ventricular cardiac function and caused Grade 3 or 4 interstitial pneumonitis.
Up to Week 14, surgical resection and post treatment
Number of participants with shift from Baseline in hematological toxicity grade
Tidsram: Day 14 and up to Week 23, surg resection and post treatment
Hematology was summarized for hemoglobin (Hb), platelets, white blood cell count (WBC), neutrophils (Neu), lymphocytes by scheduled assessment and also according to the maximum common terminology criteria (CTC) toxicity grade. Baseline was the most recent lab value prior to and within two weeks of the first dose of lapatinib. Change from Baseline was calculated as the value at each visit minus Baseline value.
Day 14 and up to Week 23, surg resection and post treatment
Number of participants with shift from Baseline in clinical chemistry toxicity grade
Tidsram: Day 14, Week 4, 8, 12, 16, 20, Surg resection and post treatment
Clinical chemistry was summarized for sodium, potassium (K), bicarbonate (bicarb), albumin (alb), calcium, gamma glutamyl transferase (GGT), creatinine (creat), total bilirubin (TB), alkaline phosphatase (ALP), aspartate amino transferase (AST) and alanine amino transferase (ALT) by scheduled assessment and also according to the maximum CTC toxicity grade. Baseline was the most recent lab value prior to and within two weeks of the first dose of lapatinib. Change from Baseline was calculated as the value at each visit minus Baseline value.
Day 14, Week 4, 8, 12, 16, 20, Surg resection and post treatment
Change from Baseline in vital signs- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
Tidsram: Day 14, Week 1 and up to Week 24, surg resection and post treatment
Vitals signs (SBP and DBP) were assessed from screening until the post treatment phase. Baseline was the most recent blood pressure (BP) mean prior to the first dose of lapatinib. Change from Baseline was calculated as the mean at each visit minus the mean at Baseline.
Day 14, Week 1 and up to Week 24, surg resection and post treatment
Change from Baseline in vital signs- Heart Rate (HR)
Tidsram: Day 14, Week 1 and up to Week 24, surg resection and post treatment
Vitals signs (HR) were assessed from screening until the post treatment phase. Baseline was the most recent BP mean prior to the first dose of lapatinib. Change from Baseline was calculated as the mean at each visit minus the mean at Baseline.
Day 14, Week 1 and up to Week 24, surg resection and post treatment
Change from Baseline in vital signs- Body temperature
Tidsram: Day 14, Week 1 and up to Week 24, surg resection and post treatment
Vitals signs (body temperature) were assessed from screening until the post treatment phase. Baseline was the most recent BP mean prior to the first dose of lapatinib. Change from Baseline was calculated as the mean at each visit minus the mean at Baseline.
Day 14, Week 1 and up to Week 24, surg resection and post treatment
Number of participants with abnormal electrocardiogram (ECG) findings
Tidsram: Screening and unscheduled
ECG was performed at screening and at unscheduled visits. Participants with abnormal clinically significant and abnormal not clinically significant ECG findings was reported.
Screening and unscheduled
Number of participants with change from Baseline in echocardiogram (ECHO) or Multi-gated angiogram (MUGA) results at any post Baseline visit
Tidsram: Screening, Week 8, 16, 24, post treatment
For ECHO and MUGA scans, the left ventricular ejection fraction (percent) was summarized for each scheduled assessment. Absolute change from Baseline was summarized according to the following categories: any increase, 0 to less than 20 percent decrease, >=20 percent decrease or >=20 percent decrease and below the lower limit of normal (LLN). Baseline was the most recent ECOG evaluation prior to the first dose of lapatinib. Change from Baseline was calculated as the value at the post treatment minus Baseline value.
Screening, Week 8, 16, 24, post treatment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Publikationer och användbara länkar

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Allmänna publikationer

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 (Faktisk)

11 april 2005

Primärt slutförande (Faktisk)

1 november 2006

Avslutad studie (Faktisk)

1 november 2006

Studieregistreringsdatum

Först inskickad

25 maj 2005

Först inskickad som uppfyllde QC-kriterierna

25 maj 2005

Första postat (Uppskatta)

26 maj 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 maj 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 maj 2017

Senast verifierad

1 maj 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • EGF102580

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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