Head and Neck NeoplasmsPhase 2NCT00514943
BIBW 2992 (Afatinib) in Head & Neck Cancer
A Phase 2 study testing BIBW 2992 and Cetuximab in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by Boehringer Ingelheim at 36 sites in 4 countries.
Trial summary
The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
- What is being tested?
- BIBW 2992 and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 36 sitesin 4 countries
- Study dates
- Aug 2007to Jul 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Metastatic (stage IVc) or recurrent HNSCC 2. Histologically or cytologically confirmed diagnosis of squamous cell of the head and neck. Patients with well-differentiated (keratinizing) nasopharyngeal carcinomas and patients with squamous cell carcinomas metastatic to the neck from an unknown head and neck primary are eligible. 3. Patients must have documented progressive disease (PD) following receipt of prior platinum-based therapy (either as neoadjuvant, adjuvant, concomitant with radiotherapy, or for recurrent/ metastatic disease). 4. Patients must have measurable disease as defined by RECIST criteria. 5. Patients must have recovered from any therapy-related toxicities from previous chemo-, immuno-, or radiotherapies to CTC smaller or equal to Grade 1. 6. Patients must have recovered from previous surgery. 7. Life expectancy of at least three (3) months. 8. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 or 1.
- 9. Patients must be eighteen (18) years of age or older. 10. Willingness and ability to give written informed consent consistent with ICH-GCP guidelines.
Who cannot join
- Progressive disease within 3 months after completion of curative intent treatment for localized/locoregionally advanced disease.
- Prior use of an EGFR or erbB2 inhibitor in the recurrent/metastatic disease setting (treatment with cetuximab (Erbitux®) or other EGFR inhibitor during radiotherapy or chemoradiotherapy is permissible).
- More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.
- Treatment with other investigational drugs, other anti-cancer-therapy (e.g., chemotherapy, immunotherapy, radiotherapy), concomitantly with therapy on this study and/or during the last four weeks, prior to the first treatment with the trial drug
- eliminated per Amendment #1
- Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.
Show all 22Show fewer
- Patients with history of decompensated heart failure.
- Cardiac left ventricular function with resting ejection fraction <50% or less than the institutional lower limit of normal by MUGA or echocardiogram.
- Active infectious disease.
- Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
- Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol.
- Use of alcohol or drugs incompatible with patient participation in the study in the investigator's opinion.
- Patients unable to comply with the protocol.
- Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal cerebral MRI scan at screening and be at least three months post-radiation or surgery.
- Absolute neutrophile count (ANC) less than 1000/mm3.
- Platelet count less than 75,000/mm3.
- Bilirubin greater than 1.5 mg/dl/ Higher bilirubin values are acceptable for patients with known Gilbert's disease, approval by the PI and sponsor necessary.
- Asparate amino transferase (AST) or alanine amino transferase (ALT) greater than 3 times the upper limit of normal.
- Serum creatinine greater than 1.5 X upper limit of normal for the institution.
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
- Pregnancy or breast-feeding.
- Patients with known pre-existing interstitial lung disease.
Trial locations and contacts
36 sites in 4 countries.
36 sites in 4 countries
United States18 sites
1200.28.0012 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan
1200.28.0024 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1200.28.0017 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina
1200.28.0013 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1200.28.0001 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1200.28.0005 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1200.28.0011 Boehringer Ingelheim Investigational Site
Harvey, Illinois
1200.28.0007 Boehringer Ingelheim Investigational Site
Houston, Texas
1200.28.0022 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
1200.28.0002 Boehringer Ingelheim Investigational Site
Jackson, Mississippi
1200.28.0009 Boehringer Ingelheim Investigational Site
Madison, Wisconsin
1200.28.0020 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
1200.28.0008 Boehringer Ingelheim Investigational Site
New Hyde Park, New York
1200.28.0006 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1200.28.0016 Boehringer Ingelheim Investigational Site
Rochester, Minnesota
1200.28.0021 Boehringer Ingelheim Investigational Site
Saint Joseph, Michigan
1200.28.0010 Boehringer Ingelheim Investigational Site
Stanford, California
1200.28.0004 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
France9 sites
1200.28.0062A Boehringer Ingelheim Investigational Site
Alès
1200.28.0062B Boehringer Ingelheim Investigational Site
Alès
1200.28.0059A Boehringer Ingelheim Investigational Site
Avignon
1200.28.0052A Boehringer Ingelheim Investigational Site
Lille
1200.28.0051A Boehringer Ingelheim Investigational Site
Lyon
1200.28.0050A Boehringer Ingelheim Investigational Site
Montpellier
1200.28.0058A Boehringer Ingelheim Investigational Site
Nîmes
1200.28.0061A Boehringer Ingelheim Investigational Site
Poitiers
1200.28.0055G Boehringer Ingelheim Investigational Site
Rouen
Spain6 sites
1200.28.0040 Boehringer Ingelheim Investigational Site
Barcelona
1200.28.0044 Boehringer Ingelheim Investigational Site
Barcelona
1200.28.0043 Boehringer Ingelheim Investigational Site
Madrid
1200.28.0042 Boehringer Ingelheim Investigational Site
Málaga
1200.28.0045 Boehringer Ingelheim Investigational Site
Santander
1200.28.0041 Boehringer Ingelheim Investigational Site
Valencia
Belgium3 sites
1200.28.0030 Boehringer Ingelheim Investigational Site
Brussels
1200.28.0031 Boehringer Ingelheim Investigational Site
Ghent
1200.28.0032 Boehringer Ingelheim Investigational Site
Leuven
About this study
Official title: A Randomized, Open-label Phase II Study of BIBW 2992 Versus Cetuximab (Erbitux) in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy With a Cross-over Period for Progressing Patients
The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
- Being tested
- BIBW 2992, Cetuximab
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBW 2992Drug
experimental drug taken once daily orally
CetuximabDrug
active comparator administered weekly intravenously
| Study group | Role | What they receive |
|---|---|---|
| BIBW 2992 | Experimental | once daily taken orally Receives: Drug: BIBW 2992 |
| Cetuximab | Active comparator | once every week by intravenous injection Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Shrinkage Before Crossover (Stage 1) of the Trial as Per Investigator Assessment
Tumor shrinkage before crossover was defined as the change from baseline in the smallest post-randomisation sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after randomisation but before crossover minus SLD at baseline. Baseline was the SLD measured before randomisation. A negative value means the smallest post-randomisation SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.
Mean calculated is actually the Adjusted mean. Adjusted mean is obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions as covariates.
Measured: From randomization until start of Stage 2 treatment, or within 28 days after the termination of Stage 1.
Secondary outcomes (21)
Tumor Shrinkage After Crossover (Stage 2) as Per Investigator Assessments
Tumor shrinkage after crossover was defined as the change from baseline in the smallest post-crossover sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after crossover minus SLD at baseline. Baseline was the SLD measured at the time of crossover, or the closest measurement before the patient started stage 2 treatment. A negative value means the smallest post-crossover SLD was smaller than baseline (decreased after crossover), a positive value means tumor size increased after crossover.
Measured: From baseline assessed prior to first dose of Stage 2 study medication to 28 days after termination of Stage 2 treatment.
Best RECIST Assessment as Per Investigator Assessment for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).
Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.
Measured: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Per ICR for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).
Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.
Measured: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Per Investigator Assessment for Stage 2 (as as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)
Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.
Measured: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Best RECIST Assessment as Per ICR for Stage2 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)
Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.
Measured: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 1
Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment for Stage 1.
Measured: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Onset of Confirmed Objective Response as as Per ICR for Stage 1
Best RECIST Assessment as onset of confirmed objective response as per the independent central review (ICR) according to the RECIST 1.0 criteria.
Measured: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 2
Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment according to the RECIST 1.0 criteria.
Measured: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 1
Best RECIST Assessment as duration of confirmed objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.
Measured: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Confirmed Duration of Confirmed Objective Response and Disease Control as Per ICR for Stage 1
Best RECIST Assessment as duration of confirmed objective response and disease control as per the independent central review (ICR) according to the RECIST 1.0 criteria.
Measured: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 2
Best RECIST Assessment as confirmed duration of objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.
Measured: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Best RECIST Assessment as Confirmed Duration of Disease Control as Per ICR for Stage 2
Best RECIST Assessment as confirmed duration of disease control as per the independent central review (ICR) assessment according to the RECIST 1.0 criteria.
Measured: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Progression Free Survival (PFS) Before Crossover Based on Investigator Assessment
PFS is defined as time from randomisation to until the occurrence of tumor progression or death, whichever occurred first, during Stage 1 of the trial.
Median is calculated from the Kaplan-Meier curve for each treatment group.
Measured: From randomisation to disease progression in Stage 1 or death whichever occurred first before crossover.
Progression Free Survival (PFS) After Crossover Based on Investigator Assessment
PFS is defined as time from first administration study medication after cross over until the occurrence of tumor progression or death, whichever came first, during Stage 2 of the trial.
Median is calculated from the Kaplan-Meier curve for each treatment group.
Measured: From first administration of study medication after cross over to disease progression in Stage 2 or death whichever came first after crossover.
Overall Survival (OS)
OS is defined as time from randomisation to death.
Median is calculated from the Kaplan-Meier curve for each treatment group.
Measured: From randomisation to data cut-off date.
Time to Deterioration in HRQoL - Stage 1
Health related Quality of Life (HRQoL) for Time to deterioration was assessed using the the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Head and Neck Cancer Module (H\&N35).
Time to deterioration in HRQoL (defined as a 10-point change towards worsening from the baseline score on a 0-100 point scale) was determined for:
- global health status (Questions 29 and 30 in EORTC QLQ C30)
- pain (Questions 9 and 19 in EORTC QLQ C30)
- swallowing (Questions 35 to 38 in EORTC QLQ-H\&N35)
Measured: From randomisation to deterioration in HRQoL scores before crossover.
Patients With AEs Resulting in Diarrhea, Skin Rash, Dose Reduction, Treatment Discontinuation and Decreased Cardiac Left Ventricular Function
Patients with adverse events (AEs) resulting in Diarrhea, Skin Rash, dose reduction, treatment discontinuation and decreased cardiac left ventricular function
Note: To asses the Decreased Cardiac left ventricular function, Left ventricular ejection fraction (LVEF) was assessed in patients treated with afatinib in Stage 1 and Stage 2 . And no patients in either group had a significant change in LVEF during Stage 1 or Stage 2 of the trial.
Measured: First administration of trial medication until 28 days after last drug administration
Incidence and Intensity of Adverse Events With Grading According CTCAE
Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
Measured: First administration of trial medication until 28 days after last drug administration
Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 15 (Cpre,ss,15)
Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.
Note: At day 15, values for afatinib 40 mg no values reported in stage 1 and stage 2.
Measured: Day 15
Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 29 (Cpre,ss,29)
Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
Note: At day 29, values for afatinib 40 mg no values reported in stage 2.
Measured: Day 29
Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 57 (Cpre,ss, 57)
Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514943
- Sponsor's protocol ID
- 1200.28
- Other IDs
- 2008-007097-38, 2008
- Status last verified
- Jun 2016
- First submitted
- 9 Aug 2007
- Last updated
- 26 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
PubMed 25057165
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Phase II Study of BIBW 2992 Versus Cetuximab (Erbitux) in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy With a Cross-over Period for Progressing Patients
- ClinicalTrials.gov ID
- NCT00514943
- Acronym / sponsor ID
- 1200.28
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Posted 25 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBW 2992 | Experimental | Drug: BIBW 2992once daily taken orally |
| Cetuximab | Active comparator | Drug: Cetuximabonce every week by intravenous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Metastatic (stage IVc) or recurrent HNSCC 2. Histologically or cytologically confirmed diagnosis of squamous cell of the head and neck. Patients with well-differentiated (keratinizing) nasopharyngeal carcinomas and patients with squamous cell carcinomas metastatic to the neck from an unknown head and neck primary are eligible. 3. Patients must have documented progressive disease (PD) following receipt of prior platinum-based therapy (either as neoadjuvant, adjuvant, concomitant with radiotherapy, or for recurrent/ metastatic disease). 4. Patients must have measurable disease as defined by RECIST criteria. 5. Patients must have recovered from any therapy-related toxicities from previous chemo-, immuno-, or radiotherapies to CTC smaller or equal to Grade 1. 6. Patients must have recovered from previous surgery. 7. Life expectancy of at least three (3) months. 8. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 or 1.
- 9. Patients must be eighteen (18) years of age or older. 10. Willingness and ability to give written informed consent consistent with ICH-GCP guidelines.
Key exclusion criteria (22 listed)
- Progressive disease within 3 months after completion of curative intent treatment for localized/locoregionally advanced disease.
- Prior use of an EGFR or erbB2 inhibitor in the recurrent/metastatic disease setting (treatment with cetuximab (Erbitux®) or other EGFR inhibitor during radiotherapy or chemoradiotherapy is permissible).
- More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.
- Treatment with other investigational drugs, other anti-cancer-therapy (e.g., chemotherapy, immunotherapy, radiotherapy), concomitantly with therapy on this study and/or during the last four weeks, prior to the first treatment with the trial drug
- eliminated per Amendment #1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBW 2992experimental drug taken once daily orally | Drug | BIBW 2992 |
| Cetuximabactive comparator administered weekly intravenously | Drug | Cetuximab |
Primary outcome
Tumor Shrinkage Before Crossover (Stage 1) of the Trial as Per Investigator Assessment
Time frame: From randomization until start of Stage 2 treatment, or within 28 days after the termination of Stage 1.
Tumor shrinkage before crossover was defined as the change from baseline in the smallest post-randomisation sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after randomisation but before crossover minus SLD at baseline. Baseline was the SLD measured before randomisation. A negative value means the smallest post-randomisation SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline. Mean calculated is actually the Adjusted mean. Adjusted mean is obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions as covariates.
21 secondary outcomes
Tumor Shrinkage After Crossover (Stage 2) as Per Investigator Assessments
Time frame: From baseline assessed prior to first dose of Stage 2 study medication to 28 days after termination of Stage 2 treatment.
Best RECIST Assessment as Per Investigator Assessment for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).
Time frame: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Per ICR for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).
Time frame: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Per Investigator Assessment for Stage 2 (as as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)
Time frame: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Best RECIST Assessment as Per ICR for Stage2 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)
Time frame: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 1
Time frame: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Onset of Confirmed Objective Response as as Per ICR for Stage 1
Time frame: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 2
Time frame: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 1
Time frame: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Confirmed Duration of Confirmed Objective Response and Disease Control as Per ICR for Stage 1
Time frame: Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment
Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 2
Time frame: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Best RECIST Assessment as Confirmed Duration of Disease Control as Per ICR for Stage 2
Time frame: Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment
Progression Free Survival (PFS) Before Crossover Based on Investigator Assessment
Time frame: From randomisation to disease progression in Stage 1 or death whichever occurred first before crossover.
Progression Free Survival (PFS) After Crossover Based on Investigator Assessment
Time frame: From first administration of study medication after cross over to disease progression in Stage 2 or death whichever came first after crossover.
Overall Survival (OS)
Time frame: From randomisation to data cut-off date.
Time to Deterioration in HRQoL - Stage 1
Time frame: From randomisation to deterioration in HRQoL scores before crossover.
Patients With AEs Resulting in Diarrhea, Skin Rash, Dose Reduction, Treatment Discontinuation and Decreased Cardiac Left Ventricular Function
Time frame: First administration of trial medication until 28 days after last drug administration
Incidence and Intensity of Adverse Events With Grading According CTCAE
Time frame: First administration of trial medication until 28 days after last drug administration
Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 15 (Cpre,ss,15)
Time frame: Day 15
Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 29 (Cpre,ss,29)
Time frame: Day 29
Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 57 (Cpre,ss, 57)
Time frame: Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25057165Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
- Related InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBW 2992 and Cetuximab in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by Boehringer Ingelheim at 36 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, France, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Shrinkage Before Crossover (Stage 1) of the Trial as Per Investigator Assessment (time frame: From randomization until start of Stage 2 treatment, or within 28 days after the termination of Stage 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.