- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00105950
Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer
A Phase II Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Lapatinib in Patients With Relapsed or Refractory Inflammatory Breast Cancer
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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Bruxelles, Belgia, 1000
- GSK Investigational Site
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Barcelona, Espanja, 08036
- GSK Investigational Site
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Barcelona, Espanja, 08035
- GSK Investigational Site
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Girona, Espanja, 17007
- GSK Investigational Site
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Madrid, Espanja, 28041
- GSK Investigational Site
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Ramat Gan, Israel, 52621
- GSK Investigational Site
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Zrifin, Israel, 70300
- GSK Investigational Site
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Ontario
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Toronto, Ontario, Kanada, M4N 3M5
- GSK Investigational Site
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Bayonne, Ranska, 64100
- GSK Investigational Site
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Lyon Cedex 08, Ranska, 69373
- GSK Investigational Site
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Marseille Cedex 09, Ranska, 13273
- GSK Investigational Site
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Paris Cedex 20, Ranska, 75970
- GSK Investigational Site
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Paris Cedex 5, Ranska, 75248
- GSK Investigational Site
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Saint-Herblain, Ranska, 44805
- GSK Investigational Site
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Sfax, Tunisia, 3000
- GSK Investigational Site
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Sfax, Tunisia, 3029
- GSK Investigational Site
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Tunis, Tunisia, 1007
- GSK Investigational Site
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Tunis, Tunisia, 1004
- GSK Investigational Site
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London, Yhdistynyt kuningaskunta, SW3 6JJ
- GSK Investigational Site
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Florida
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Miami, Florida, Yhdysvallat, 33136-1002
- GSK Investigational Site
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Illinois
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Chicago, Illinois, Yhdysvallat, 60637
- GSK Investigational Site
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Zion, Illinois, Yhdysvallat, 60099
- GSK Investigational Site
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Maryland
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Bethesda, Maryland, Yhdysvallat, 20892-1201
- GSK Investigational Site
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Michigan
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Detroit, Michigan, Yhdysvallat, 48201
- GSK Investigational Site
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Missouri
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St. Louis, Missouri, Yhdysvallat, 63110
- GSK Investigational Site
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North Carolina
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Durham, North Carolina, Yhdysvallat, 27710
- GSK Investigational Site
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Washington
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Seattle, Washington, Yhdysvallat, 98109
- GSK Investigational Site
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion criteria:
- Must have a life expectancy of at least 12 weeks.
- Has a left ventricular ejection fraction (LVEF) ≥ 50%, or ≥ lower limit of normal for the institution, based on ECHO or MUGA.
- Aspartate and alanine transaminase (AST or ALT) ≤ 3 times the upper limit of the reference range (patients with liver metastases may have AST and ALT ≤ 5 times the upper limit of the reference range and may be enrolled).
- Total bilirubin ≤ 3.0 mg/dL.
- Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance (CrCl) ≥ 30 mL/min
- Adequate bone marrow function. Hemoglobin ≥ 9 gm/dL. Absolute granulocyte count ≥ 1,500/mm³ (1.5 x 10^9/L). Platelets ≥ 75,000/mm³ (100 x 10^9/L).
- Recovered or stabilized sufficiently from side effects associated with previous chemotherapy, surgery or radiotherapy.
- Provided written informed consent.
- ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2.
- Able to swallow and retain oral medication.
- Male or female, if female:
A female is eligible to enter and participate in the study if she is of:
- Non-childbearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal); or
- Childbearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. This category includes women with oligomenorrhoea (severe), women who are perimenopausal, and young women who have begun to menstruate), has a negative serum pregnancy test at screening, and agrees to one of the following where considered acceptable to the local IRB/IEC: Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm).
Abstinence from sexual intercourse from 2 weeks prior to administration of the investigational product, throughout the active study treatment period, and through the post-treatment follow-up visit (to occur 28 days after last dose of investigational product).
Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject.
Implants of levonorgestrel. Injectable progestogen. Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
Oral contraceptives (either combined or progestogen only). Barrier methods including diaphragm or condom with a spermicide.
- At least 18 years of age.
- Has either measurable disease by Response Evaluation Criteria in Solid Tumors (RESIST) or clinically evaluable skin disease. Measurable lesions may be in the field of prior adjuvant irradiation; however, there must be at least an 8 week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable.
- Tumor that is accessible for biopsy.
- Tumor that overexpresses ErbB2 defined as 3+ by IHC or FISH +. The ErbB 2 overexpression must be documented prior to dosing.
- Documented disease progression or relapse following treatment, which must have contained a taxane and anthracycline-containing regimen in the adjuvant or metastatic setting (30 patients) plus trastuzumab (90 patients)
- Histological diagnosis of breast carcinoma with a clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast. Pathologic evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
Exclusion criteria:
- Is clinically assessed to have inadequate venous access for protocol-related blood draws.
- Has a clinically significant electrocardiogram (ECG) abnormality.
- Has Class II to IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Has physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Is currently receiving oral steroid treatment (inhaled steroids are permitted), or any other medication on the prohibited medications list
- Is currently receiving amiodarone or has received amiodarone in the 6 months prior to screening.
- Has received chemotherapy, immunotherapy, biologic therapy or hormonal therapy within the past 14 days, with the exception of mitomycin C within the past 6 weeks.
- Has received treatment with any investigational drug in the previous 4 weeks.
- Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product. These include other anilinoquinazolines, such as gefitinib [Iressa], erlotinib [Tarceva], or other chemically related compounds.
- Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
- Has evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease. Patients with brain metastases treated by surgery and/or radiotherapy are eligible if neurologically stable and do not require steroids or anticonvulsants.
- Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the stomach or small bowel.
- Is a pregnant or lactating female.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Lapatinib
Single arm study of lapatinib with no comparator arm.
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Tyrosine kinase inhibitor administered daily at 1500 mg/kg
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Objective Response rate (complete response plus partial response)
Aikaikkuna: Week 84
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Week 84
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Clinical benefit (progression free survival, time to progression, response duration)
Aikaikkuna: week 84
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week 84
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Assessment of clinical benefit, defined as CR or PR for at least 4 weeks, or SD for at least 6 months
Aikaikkuna: week 84
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week 84
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Calculation of progression-free survival, defined as the time between the first dose of investigational product and the first documented sign of disease progression or death.
Aikaikkuna: week 84
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week 84
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Calculation of time-to-response, defined as the time between the first dose of investigational product and the first documented CR or PR.
Aikaikkuna: week 84
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week 84
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Calculation of duration of response, defined as the time from initial documented CR or PR to the first documented sign of disease progression.
Aikaikkuna: week 84
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week 84
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Evaluation of changes in QoL and pain scale measurements collected on Day 1 and every 4 weeks while receiving study treatment.
Aikaikkuna: week 84
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week 84
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Evaluation of adverse events (AEs), changes in laboratory values and echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) results from pre-dose, during dosing and post-dose assessments
Aikaikkuna: week 84
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week 84
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Comparison of the effects of lapatinib on biomarkers that are involved in regulating tumor cell proliferation and survival (e.g., phosphorylated forms of Erk1/2 and Akt, STAT3, S6 Kinase, Bad, truncated ErbB2 and potentially other downstream mediators of
Aikaikkuna: Day 28
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Day 28
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tumor cell growth and survival) by quantitative IHC and by direct and genome-wide methods (e.g., direct sequencing and DNA microarray) in tumor tissue collected prior to and following 28 days of lapatinib monotherapy.
Aikaikkuna: Day 28
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Day 28
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Examination of the effects of lapatinib therapy on the levels of circulating ErbB1 and ErbB2 ECD and the proteomic profile of peripheral blood. Investigation of the use of FDG-PET to predict early response to treatment with lapatinib.
Aikaikkuna: Day 28
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Day 28
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Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Kaufman B, Trudeau M, Awada A, Blackwell K, Bachelot T, Salazar V, DeSilvio M, Westlund R, Zaks T, Spector N, Johnston S. Lapatinib monotherapy in patients with HER2-overexpressing relapsed or refractory inflammatory breast cancer: final results and survival of the expanded HER2+ cohort in EGF103009, a phase II study. Lancet Oncol. 2009 Jun;10(6):581-8. doi: 10.1016/S1470-2045(09)70087-7. Epub 2009 Apr 24.
- Kaufman B, Wu Y, Amonkar MM, Sherrill B, Bachelot T, Salazar V, Viens P, Johnston S. Impact of lapatinib monotherapy on QOL and pain symptoms in patients with HER2+ relapsed or refractory inflammatory breast cancer. Curr Med Res Opin. 2010 May;26(5):1065-73. doi: 10.1185/03007991003680323.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- EGF103009
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital ja muut yhteistyökumppanitValmisConebeam Breast CT:n kliininen käyttöopasKiina
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Alexandria UniversityValmisHyvänlaatuinen rintasairaus | Kanava Ectasia BreastEgypti
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Aga Khan UniversityValmisRintasyöpä | Perforaattoriläppä | Rintakasvain | Onkoplastia | Breast-QPakistan
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Gangnam Severance HospitalRekrytointiHER2 Rikastettu alatyyppi Breast Cancer, Herzuma, PAM50 -tutkimusKorean tasavalta
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Novartis PharmaceuticalsValmisMetastaattinen rintasyöpä (MBC) | Locally Advance Breast Cancer (LABC)Yhdistynyt kuningaskunta, Espanja
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BioNTech SESeventh Framework ProgrammeValmisRintasyöpä (TNBC (Triple Negative Breast Cancer))Ruotsi, Saksa
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The University of New South WalesNational Health and Medical Research Council, Australia; Novo Nordisk A/S; Sydney Children's Hospitals NetworkValmisTyypin 1 diabetes | Murrosikä: >Tanner 2 Breast Development tai kivekset >4mlAustralia
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Fudan UniversityRekrytointiRintasyöpä | Rintojen kasvain | Rintojen kasvaimet | HER2-positiivinen rintasyöpä | Paikallisesti edennyt rintasyöpä | HER2-negatiivinen rintasyöpä | Hormonireseptoripositiivinen kasvain | Hormonireseptorinegatiivinen kasvain | Varhaisvaiheen rintasyöpä | Triple-negative Breast Cancer (TNBC)Kiina
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiivinen, ei rekrytointiInvasiivinen rintasyöpä | Vaiheen IA rintasyöpä AJCC v7 | Vaiheen IB rintasyöpä AJCC v7 | Vaiheen II rintasyöpä AJCC v6 ja v7 | Stage IIA Breast Cancer AJCC v6 ja v7 | Vaiheen IIB rintasyöpä AJCC v6 ja v7 | Ductal Breast Carcinoma In Situ | I vaiheen rintasyöpä AJCC v6Yhdysvallat
Kliiniset tutkimukset lapatinib
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GlaxoSmithKlineLopetettuKasvaimet, rintaItalia, Yhdistynyt kuningaskunta
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National Cancer Institute (NCI)ValmisMetastaattinen levyepiteelisyöpä ja okkulttinen ensisijainen syöpä | Toistuva etäpesäkkeinen niskan levyepiteelisyöpä ja okkulttinen ensisijainen syöpä | Toistuva hypofarynksin okasolusyöpä | Toistuva kurkunpään okasolusyöpä | Huulen ja suuontelon toistuva okasolusyöpä | Toistuva suunnielun okasolusyöpä ja muut ehdotYhdysvallat
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National Cancer Institute (NCI)ValmisGlioma | Aivokasvain | Glioblastoma Multiforme | Gliosarkooma | GBM | GSYhdysvallat
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University of California, San FranciscoNational Cancer Institute (NCI)ValmisRintasyöpä | Metastaattinen syöpäYhdysvallat
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University of California, DavisBristol-Myers Squibb; National Cancer Institute (NCI); Genentech, Inc.LopetettuMäärittelemätön aikuisen kiinteä kasvain, protokollakohtainenYhdysvallat
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National Cancer Institute (NCI)Gynecologic Oncology GroupValmisToistuva kohdun limakalvon karsinoomaYhdysvallat
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Jonsson Comprehensive Cancer CenterGlaxoSmithKlineValmis
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National Cancer Institute (NCI)ValmisHER2/Neu-positiivinen | Ductal Breast Carcinoma In SituYhdysvallat
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Queen Mary University of LondonGlaxoSmithKlineTuntematonVirtsarakon syöpäYhdistynyt kuningaskunta