EUCTR2004-001905-93-ES
Active, not recruiting
Phase 1
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 - Lapatinib combined with paclitaxel in newly diagnosed inflammatory breast cancer (IBC)
GlaxoSmithKline R&D Ltd0 sites0 target enrollmentJune 8, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ewly diagnosed infammatory breast cancer (IBC)
- Sponsor
- GlaxoSmithKline R&D Ltd
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically confirmed breast carcinoma with clinical diagnosis of IBC
- •\- 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\.
- •ErbB1 and ErbB2 status must be documented prior to dosing.
- •\- Tumour that is accessible for multiple biopsies
- •\- 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
- •\- Received prior biological, cytotoxic or hormonal therapy for breast cancer
- •\- Female who is pregnant or lactating
- •\- Patient who has malabsorption syndrome, disease affecting GI function, or resection of the stomach or small bowel
- •\- Considered medically unfit by the investigator
- •\- Has known hypersensitivity reaction or idiosyncrasy to drugs chemically\-related to the IMPs
- •\- Received treatment with any investigational drug in previous 4 weeks
- •\- Currently receiving amiodarone or within 6 months prior to screening
- •\- Currently receiving oral steroid treatment, or any other protocol\-specified prohibited medication. Use of cimetidine and/or steroids is permitted when required as standard treatment for paclitaxel administration.
- •\- Had major surgery within previous 2 weeks
- •\- Has condition/s which will not permit compliance with the protocol
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
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 - Lapatinib combined with paclitaxel in newly diagnosed inflammatory breast cancer (IBC)ewly diagnosed infammatory breast cancer (IBC)EUCTR2004-001905-93-GBGlaxoSmithKline R&D Ltd60
Active, not recruiting
Not Applicable
A phase II study to assess the efficacy and safety of frontline combination of dasatinib (SPRYCEL®) and pegylated-interferon alpha 2b (Peg-IFNa2b) therapy in patients newly diagnosed with chronic phase chronic myeloid leukaemia (CP-CML) - DASA-PEGIFPatients with newly diagnosed chronic phase Chronic Myeloid Leukemia (CP-CML), not previously treated with Tyrosine Kinase Inhibitors (TKIs). First line therapy.MedDRA version: 14.1Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2012-003389-42-FRCHU DE POITIERS
Active, not recruiting
Phase 1
A study to investigate whether adding a new hormone treatment for breast cancer, called Irosustat, to current hormone treatment (aromatase inhibitor) can affect the growth of breast cancer.EUCTR2011-005680-25-GBImperial College London28
Active, not recruiting
Phase 1
A study assessing the efficacy and safety of an investigational drug called fidrisertib (IPN60130) for the treatment of fibrodysplasia ossificans progressiva in male and female paediatric and adult participantsEUCTR2020-002858-24-SEClementia Pharmaceuticals Inc, an Ipsen Company98
Not yet recruiting
Phase 2
A Phase 2 study to assess the efficacy and safety of 2 dosage regimens of oral fidrisertib (IPN60130) for the treatment of fibrodysplasia ossificans progressiva in male and female paediatric and adult participantsNL-OMON54489Ipsen Pharmaceuticals5