EUCTR2004-001906-29-GB
Active, not recruiting
Phase 1
Phase II study to evaluate the efficacy, safety and pharmacodynamics of lapatinib in patients with relapsed or refractory inflammatory breast cancer - Lapatinib in relapsed or refractory inflammatory breast cancer (IBC)
GlaxoSmithKline R&D Ltd0 sites0 target enrollmentJune 13, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed or refractory infammatory breast cancer (IBC)
- Sponsor
- GlaxoSmithKline R&D Ltd
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically confirmed breast carcinoma with clinical diagnosis of IBC
- •\- Documented disease progression or relapse following treatment, which must have included a taxane and anthracycline\-containing regimen in the adjuvant or metastatic setting (30 patients) plus trastuzumab (90 patinets)
- •\- Tumour that overexpresses ErbB2 as 3\+ by IHC or FISH\-positive. The ErbB2 expression status must be documented prior to dosing.
- •\- Must have life expectancy of at least 12 weeks
- •\- Tumour to be accessible for biopsy
- •\- Measureable disease by RECIST or clinically evaluable skin disease
- •\- Male or female at least 18 years of age
- •\- Female patients must either be of non\-childbearing potential, or if of childbearing potential to have negative serum pregnancy test at screening and to agree to a protocol\-specified method of contraception during participation in the study
- •\- Able to swallow and retain oral medication
- •\- ECOG performance status 0\-2
Exclusion Criteria
- •\- Female who is pregnant or lactating
- •\- Patient who has malabsorption syndrome, disease affecting GI function, or resection of the stomach or small bowel
- •\- 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.
- •\- Considered medically unfit by the investigator
- •\- Has known hypersensitivity reaction or idiosyncrasy to drugs chemically\-related to the IMP
- •\- Received treatment with any investigational drug in previous 4 weeks
- •\- Has received chemotherapy, immunotherapy, biologic therapy or hormonal therapy within the past 14 days (except mitomycin C within past 6 weeks)
- •\- Currently receiving amiodarone or within 6 months prior to screening
- •\- Currently receiving oral steroid treatment, or any other protocol\-specified prohibited medication
- •\- Has condition/s which will not permit compliance with the protocol
Outcomes
Primary Outcomes
Not specified
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