EUCTR2004-001906-29-BE
Active, not recruiting
Not Applicable
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 sites60 target enrollmentFebruary 15, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Relapsed or refractory infammatory breast cancer (IBC)
- Sponsor
- GlaxoSmithKline R&D Ltd
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 11 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 an anthracycline\-containing regimen
- •\- Tumour that:\-
- •Cohort A \- overexpresses ErbB2 (defined IHC 2\+ or 3\+, or FISH\-positive) with or without expression of ErbB1 (by IHC), or
- •Cohort B \- expression of ErbB1 (defined as IHC \+) without overexpression of ErbB2
- •\- 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
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
Similar Trials
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)Relapsed or refractory infammatory breast cancer (IBC)MedDRA version: 8.1 Level: LLT Classification code 10021974 Term: Inflammatory breast cancerEUCTR2004-001906-29-GBGlaxoSmithKline R&D Ltd
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.Relapsed or refractory infammatory breast cancer (IBC)MedDRA version: 14.1Level: LLTClassification code 10021974Term: Inflammatory breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2004-001906-29-ESGlaxoSmithKline R&D Ltd
Active, not recruiting
Not Applicable
Safety and efficacy of combined treatment with ipilimumab and intratumoral interleukin-2 in pretreated patients with metastatic melanomaStage IV MelanomaMedDRA version: 14.0Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2010-019033-98-DEniversity Clinical Center of Tuebingen
Recruiting
Phase 2
Evaluation of the efficacy of bioadhesive barrier-forming oral liquid gel (Episil) for prevention of oral mucositisJPRN-jRCTs062220023Takano HIdeyuki50
Active, not recruiting
Phase 1
A Phase 2 study to evaluate the safety and efficacy of EP0057 in combination with Olaparib in advanced ovarian cancer patientsAdvanced ovarian cancer patients who have: Cohort 1 – platinum resistant disease and are PARP inhibitor naïveCohort 2 – had at least 1 prior line of therapy which must include at least 1 line of platinum-based chemotherapy followed by PARP inhibitor maintenanceMedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2020-003083-98-HUEllipses Pharma Limited384