Health Condition 1: null- Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma.
Conditions
Interventions
Intervention1: BIBW 2992: Dose: Starting dose 40 mg daily, escalation to 50 mg/day and/or reduction to 40, 30 then 20
mg according to absence or presence of drug related adverse events.
Mode of admin
Sponsors
Boehringer Ingelheim India Pvt Ltd
Eligibility
Inclusion 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
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 glands • 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 CTCAE grade 1 and/or diarrhoea CTCAE grade 1 caused by prior treatment with EGFR targeted antibodies. • Any past or present history of areca/betel-nut chewing or its derivatives for a cumulative duration of more than 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) based on RECIST version 1.1Timepoint: At screening (within 21 days prior to start of treatment (Visit 2) is accepted if compliant with central imaging requirements) â?? Every 6 weeks after Visit 2 â?? Every 8 weeks after treatment week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Health related quality of life (HRQOL)Timepoint: Every 8 weeks while on treatment;Objective response based on RECIST version 1.1Timepoint: At screening (within 21 days prior to start of treatment (Visit 2) is accepted if compliant with central imaging requirements) â?? Every 6 weeks after Visit 2 â?? Every 8 weeks after treatment week 24.;Overall survival (OS) Timepoint: Every 4 weeks after last Follow-up visit | — |
Countries
China, Egypt, Hong Kong, India, Philippines, Republic of Korea, Taiwan
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim India Pvt Ltd
Outcome results
None listed