A Phase 3 interventional study of Placebo and Afatinib in Head and Neck Neoplasms, sponsored by Boehringer Ingelheim. Terminated at 162 sites in 29 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-07.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 617 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Once daily
Drug: Afatinib
Once daily
Drug: Placebo
Once daily
Once daily
Disease Free Survival (DFS)
Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.
Time frame: Up to 5 years
Disease Free Survival (DFS) Rate at 2 Years
Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.
Time frame: Up to 2 years
Percentage of Patient Deaths (Overall Survival (OS))
Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.
Time frame: Up to 5 years
Patients With Improved Health Related Quality of Life (HRQOL)
HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.
Time frame: Up to 5 years
Time to Deterioration in Health Related Quality of Life (HRQOL)
HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.
Time frame: Up to 5 years
Health Related Quality of Life (HRQOL) Scores Over Time
HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.
Time frame: Baseline and 5 years
| Milestone | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
| Started | 411 | 206 |
| Completed | 124 | 87 |
| Not completed | 287 | 119 |
| Withdrew: Primary tumour recurrence | 53 | 32 |
| Withdrew: Second primary tumour | 4 | 3 |
| Withdrew: Adverse event | 63 | 9 |
| Withdrew: Protocol violation | 3 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 52 | 13 |
| Withdrew: Other reasons | 111 | 60 |
Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.
| Months | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
| Disease Free Survival (DFS) | 43.40 (16.82 to NA) | NA (16.69 to NA) |
Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.
| Probability (%) | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
| Disease Free Survival (DFS) Rate at 2 Years | 67.2 (61.2 to 72.5) | 73.5 (66.0 to 79.5) |
Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.
| Percentage of patients | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
| Percentage of Patient Deaths (Overall Survival (OS)) | 15.1 (16.82 to NA) | 11.2 (16.69 to NA) |
HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.
| Percentage of Patients | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
| Swallowing (Q5-Q8 from QLQ-HN35) | 34.8 (16.82 to NA) | 27.2 (16.69 to NA) |
| Pain HN35 (Q1-Q4 from QLQ-HN35) | 33.8 | 26.2 |
| Global health status/QoL(Q29-Q30 from QLQ-C30) | 33.6 | 38.3 |
HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.
| Months | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
| Swallowing | 18.43 (3.68 to NA) | 31.44 (3.78 to NA) |
| Pain HN35 | 12.06 (1.91 to NA) | 31.08 (3.78 to NA) |
| Global health status/QoL | 7.59 (1.87 to NA) | 25.79 (6.21 to NA) |
HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.
| Unit on Scale | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
| Swallowing | 10.1 ± 1.00 | 8.8 ± 1.12 |
| Pain HN35 | 13.1 ± 0.98 | 9.9 ± 1.10 |
| Global health status/QoL | 29.6 ± 2.23 | 33.0 ± 2.28 |
Collected over From first drug administration until 4 weeks after the last drug administration, up to 84 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Afatinib (BIBW 2992) | — | 80/411 (19.5%) | 407/411 (99%) |
| Placebo | — | 51/206 (24.8%) | 169/206 (82%) |
| Event | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
| Laryngeal oedemaRespiratory, thoracic and mediastinal disorders | 8/411 | 8/206 |
| PneumoniaInfections and infestations | 1/411 | 5/206 |
| OsteonecrosisMusculoskeletal and connective tissue disorders | 0/411 | 3/206 |
| Neoplasm recurrenceNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/411 | 3/206 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/411 | 3/206 |
| AnaemiaBlood and lymphatic system disorders | 4/411 | 2/206 |
| ArrhythmiaCardiac disorders | 0/411 | 2/206 |
| Decreased appetiteMetabolism and nutrition disorders | 3/411 | 1/206 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/411 | 0/206 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 3/411 | 0/206 |
| Event | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 335/411 | 41/206 |
| RashSkin and subcutaneous tissue disorders | 188/411 | 34/206 |
| Mucosal inflammationGeneral disorders | 126/411 | 17/206 |
| Dermatitis acneiformSkin and subcutaneous tissue disorders | 112/411 | 6/206 |
| StomatitisGastrointestinal disorders | 107/411 | 12/206 |
| ParonychiaInfections and infestations | 85/411 | 4/206 |
| Dry skinSkin and subcutaneous tissue disorders | 76/411 | 16/206 |
| Decreased appetiteMetabolism and nutrition disorders | 74/411 | 23/206 |
| Weight decreasedInvestigations | 67/411 | 19/206 |
| FatigueGeneral disorders | 61/411 | 21/206 |
Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)
| Age, Continuous(Years) | Afatinib (BIBW 2992) | Placebo | Total |
|---|---|---|---|
| Mean | 58.3 ± 8.23 | 57.3 ± 8.64 | 58.0 ± 8.38 |
| Sex: Female, Male(Participants) | Afatinib (BIBW 2992) | Placebo | Total |
|---|---|---|---|
| Female | 61 | 28 | 89 |
| Male | 350 | 178 | 528 |
Showing the first 100 of 162 sites across 29 countries.
This study is terminated, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim