WHO ICTRP trial
Evaluation of efficacy and safety of Afatinib (BIBW 2992) vs. placebo as…
CTRI/2014/02/004416 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2014/02/004416 |
|---|---|
| Public title | Evaluation of efficacy and safety of Afatinib (BIBW 2992) vs. placebo as adjuvant therapy after chemo-radiotherapy in primarily patients with non-surgical intervention with a stage III, IVa or IVb locally advanced Head and Neck squamous cell carcinoma |
| Scientific title | A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemo-radiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinoma… |
| Primary sponsor | Boehringer Ingelheim Danmark AS |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | Peru;Poland;Portugal;Spain;Sweden;Switzerland;United Kingdom;United States of America;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Czech… |
| Conditions | Health Condition 1: null- Loco-Regionally advanced Head and Neck Squamous Cell Carcinoma |
| Interventions | Intervention1: Afatinib 20mg,30mg,40mg and 50 mg film coated tablets: Daily Dose - 1 tablet. Starting dose 40 mg. The dose is escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg. Continuous daily dosing for up to 80 weeks (about 18… |
| Registration date | Feb 18, 2014 |
| Target size | 669 |
| Secondary IDs | 1200.131, Version 1 dated 22 Jan 2013 - India Amendment;1200.131, Version 3 dated 28 Jun 2012 - Global Protocol;2011-000392-14 |
| Registry page | ctri.nic.in |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: