CTRI/2014/08/004896
Recruiting
Phase 3
A randomised, open-label, phase III study to evaluate the efficacy andsafety of oral afatinib (BIBW 2992) versus intravenous methotrexate inpatients with recurrent and/or metastatic head and neck squamous cellcarcinoma who have progressed after platinum-based therapy - LUX-Head & Neck 3
Boehringer Ingelheim India Pvt Ltd0 sites300 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma.
- Sponsor
- Boehringer Ingelheim India Pvt Ltd
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed squamour cell carcinoma of the roal cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable for salvage surgery or radiotherapy
- •Documented porgressive deisase based on investigator assessment according to RECIST, following receipt of cisplatin and or carboplatin based regimen administered for recurrent and or metastatic disease independent of whether patient progressed during or after platinumbased therapy.
- •Measurable disease according to RECIST 1\.1
- •ECOG performance status 1 or 1 at visit 2\.
Exclusion Criteria
- •Progressive disease within three months of completion of curatively intended
- •treatment for locoregionally advanced HNSCC or for metastatic HNSCC.
- •Primary tumour site nasopharynx (of any histology), sinuses, and/or salivary
- •Any other than one previous platinum\-based systemic regimen given for recurrent
- •and/or metastatic disease. Re\-challenge with the first line regimen after a
- •temporary break is considered a second line regimen only in case of progression
- •within the break.
- •Prior treatment with EGFR\-targeted small molecules.
- •Unresolved chronic toxicity, other than hearing loss, tinnitus or dry mouth,
- •CTCAE grade 2 from previous anti\-cancer therapy or unresolved skin toxicities
Outcomes
Primary Outcomes
Not specified
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