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EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
 Type
 Status
 Age
 Sponsor
 Protocol IDs

Phase IV
Treatment
Active
18 and over
Pharmaceutical / Industry
EGF103659
NCT00338247

Trial Description

Summary

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

Eligibility Criteria

Inclusion criteria:

  • May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted.
  • Prior treatment with hormonal therapy is allowed.
  • Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting.
  • Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.
  • Must be >/= 18 years of age
  • Life expectancy of > 8 weeks
  • Must have recovered from side effects of previous treatment
  • Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required
  • Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed
  • Able to swallow and retain oral medications
  • Must have adequate hematologic, hepatic and renal function

Exclusion criteria:

  • Pregnant or lactating females
  • Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis
  • Concurrent disease or condition that would make the patient inappropriate for study participation
  • Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment
  • Uncontrolled infection
  • Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient
  • Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed
  • History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients
  • History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients
  • Known DPD deficiency

Trial Contact Information

Trial Lead Organizations/Sponsors

GlaxoSmithkline

GSK Clincial Trials, MDStudy Director

Trial Sites

Belgium
  Brussels
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Bruxelles
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Charleroi
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Edegem
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Gent
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Haine St Paul
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Leuven
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Liege
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Wilrijk
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Yvoir
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Canada
Ontario
  Oshawa
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Saskatoon
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Sudbury
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Quebec
  Greenfield
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
China
  Beijing
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Dalian
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Guangzhou
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Hangzhou
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Nan Jing
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Shanghai
 Lapatinib EAP Call Center
 GSK Clinical Trials Call Center Ph: 1 888-489-5372
  Shanghai, Beijing
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Tianjin
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Cyprus
  Nicosia
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Czech Republic
  Brno
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Olomouc
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Praha
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Israel
  Beer-Sheva
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Haifa
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Jerusalem
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1-888-489-5372
  Petach-Tikva
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Ramat Gan
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Rehovot
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Tel Aviv
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Italy
  Ancona
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Aviano-Pordenone
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Bari
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Bergamo
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Bolzano
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Cagliari
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Chieti
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Firenze
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Forli
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Genova
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Macerata
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Milano
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Modena
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Napoli
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Padova
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Palermo
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Perugia
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Pisa
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Potenza
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Reggio Calabria
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Roma
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  San Giovanni Rotondo (FG)
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Torino
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Trieste
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Luxembourg
  Luxembourg
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Malta
  Floriana
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Mexico
  Durango
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Merida
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Tijuana
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Toluca
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Peru
  Lima 13
 Lapatinib EAP Call Center
 GSK Clinical Trials Call Center Ph: 1 888-489-5372
  Lima 34
 Lapatinib EAP Call Center
 GSK Clinical Trials Call Center Ph: 1 888-489-5372
Poland
  Bialystok
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Bydgoszcz
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Elblag
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Gdansk
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Gliwace
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Olsztyn
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Poznan
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Warszawa
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Portugal
  Evora
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Lisboa
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Lisbon
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Porto
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Romania
  Bucharest
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Iasi
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Sibiu
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Timisoara
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Slovenia
  Ljubljana
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Maribor
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1
Sweden
  Jonkoping
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Lund
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Stockholm
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Umea
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Uppsala
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Taiwan, Province of China
  Kaohsiung
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Taichung
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Tainan
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Taipei
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Thailand
  Chiang Mai
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Pathumthani
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Pathumwan, Bangkok
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Patumwan, Bangkok
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Wattana, Bangkok
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
Ukraine
  Chernivtsy
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Kiev
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Odessa
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372
  Rovno
 Lapatinib EAP Call Center
 Lapatinib EAP Call Center Ph: 1 888-489-5372

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00338247
Information obtained from ClinicalTrials.gov on September 10, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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