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Trial record 4 of 73 for:    inflammatory breast cancer AND Complete Response

Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer

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ClinicalTrials.gov Identifier: NCT01325428
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : February 11, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Neoplasms
Interventions Drug: Afatinib once daily (OD)
Drug: Vinorelbine Weekly
Enrollment 26

Recruitment Details This was an open-label study conducted in two sequential parts (Part A in which patients were treated with Afatinib (BIBW 2992) as monotherapy; Part B in which patients were treated with Afatinib plus Vinorelbine as combination therapy after progression on Afatinib monotherapy).
Pre-assignment Details Part A: Patients were treated with Afatinib and could continue on treatment until first Progression of Disease (PD), intolerable side effects, or withdrawal of consent. Upon first PD, patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with weekly Vinorelbine.
Arm/Group Title Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).
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Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.

Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.

Period Title: Part A
Started 26
Completed 10
Not Completed 16
Reason Not Completed
Progressive disease according to RECIST             9
Clinical signs, symptoms of progression             2
Other adverse event             1
Refused continue taking trial medication             2
Other reason not defined above             2
Period Title: Part B
Started 10
Completed 7
Not Completed 3
Reason Not Completed
Refused continue taking trial medication             2
Other reason not defined above             1
Arm/Group Title Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine).
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Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.

Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
TRT A Treated set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
Part A 51.5  (8.8)
Part B 51.5  (12.5)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Female (Part A) 26
Female (Part B) 10
Male (Part A) 0
Male (Part B) 0
1.Primary Outcome
Title Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Hide Description Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
Time Frame This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Hide Analysis Population Description
TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
Arm/Group Title Part A: Afatinib Once Daily (OD).
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Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.

The 95% Confidence Interval is Exact Confidence Interval.

Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
35
(17 to 56)
2.Primary Outcome
Title Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Hide Description Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
Time Frame This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
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Hide Analysis Population Description
TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Arm/Group Title Part B: Afatinib Once Daily (OD)+V (Vinorelbine).
Hide Arm/Group Description:
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
20
(3 to 56)
3.Secondary Outcome
Title Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Hide Description Objective response was defined on a patient level as a best response of CR or PR.
Time Frame This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Hide Analysis Population Description
TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
Arm/Group Title Part A: Afatinib Once Daily (OD).
Hide Arm/Group Description:
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
31
(14 to 52)
4.Secondary Outcome
Title Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Hide Description Objective response was defined on a patient level as a best response of CR or PR.
Time Frame This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
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Hide Analysis Population Description
TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Arm/Group Title Part B: Afatinib Once Daily (OD)+V (Vinorelbine).
Hide Arm/Group Description:
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
10
(0 to 45)
5.Secondary Outcome
Title Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Hide Description Objective response was defined on a patient level as a best response of CR or PR.
Time Frame This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
Arm/Group Title Part A: Afatinib Once Daily (OD).
Hide Arm/Group Description:
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
42
(23 to 63)
6.Secondary Outcome
Title Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
Hide Description Objective response was defined on a patient level as a best response of CR or PR.
Time Frame This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Arm/Group Title Part B: Afatinib Once Daily (OD)+V (Vinorelbine).
Hide Arm/Group Description:
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
30
(7 to 65)
7.Secondary Outcome
Title Part A: Duration of Unconfirmed Objective Response.
Hide Description Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).
Time Frame From first drug administration until end of Part A, up to 929 days.
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Hide Analysis Population Description
TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
Arm/Group Title Part A: Afatinib Once Daily (OD).
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Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(57 to NA)
[1]
The Kaplan Meier (KM) probability never falls to 0.5 therefore the median can't be estimated. Not Applicable (NA).
8.Secondary Outcome
Title Part B: Duration of Unconfirmed Objective Response.
Hide Description Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).
Time Frame From first drug administration until end of Part B, up to 929 days.
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Hide Analysis Population Description
TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Arm/Group Title Part B: Afatinib Once Daily (OD)+V (Vinorelbine).
Hide Arm/Group Description:
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
Overall Number of Participants Analyzed 3
Median (95% Confidence Interval)
Unit of Measure: Days
57
(56 to 140)
9.Secondary Outcome
Title Part A: Progression Free Survival.
Hide Description PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A.
Time Frame From first drug administration until end of Part A, up to 713 days.
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Hide Analysis Population Description
TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
Arm/Group Title Part A: Afatinib Once Daily (OD).
Hide Arm/Group Description:
Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: Days
110.5
(58.0 to 386.0)
10.Secondary Outcome
Title Part B: Progression Free Survival.
Hide Description PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B.
Time Frame From first drug administration until end of Part B, up to 230 days.
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Hide Analysis Population Description
TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
Arm/Group Title Part B: Afatinib Once Daily (OD)+V (Vinorelbine).
Hide Arm/Group Description:
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: Days
106.0
(36.0 to 190.0)
11.Secondary Outcome
Title Progression Free Survival Over the Whole Sudy.
Hide Description PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.
Time Frame From first drug administration until end of study, up to 700 days.
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Hide Analysis Population Description

TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.

TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.

Arm/Group Title Afatinib Once Daily (OD). Afatinib+V (Vinorelbine).
Hide Arm/Group Description:

Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.

Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.

Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: Days
253.0
(166.0 to 713.0)
Time Frame Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
Adverse Event Reporting Description The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
 
Arm/Group Title Part A: Afatinib Once Daily (OD). Part B: Afatinib+V (Vinorelbine).
Hide Arm/Group Description Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
All-Cause Mortality
Part A: Afatinib Once Daily (OD). Part B: Afatinib+V (Vinorelbine).
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part A: Afatinib Once Daily (OD). Part B: Afatinib+V (Vinorelbine).
Affected / at Risk (%) Affected / at Risk (%)
Total   12/26 (46.15%)   4/10 (40.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/26 (0.00%)  1/10 (10.00%) 
Diarrhoea  1  3/26 (11.54%)  1/10 (10.00%) 
Nausea  1  0/26 (0.00%)  1/10 (10.00%) 
Vomiting  1  3/26 (11.54%)  1/10 (10.00%) 
General disorders     
Asthenia  1  0/26 (0.00%)  1/10 (10.00%) 
Fatigue  1  1/26 (3.85%)  0/10 (0.00%) 
Pain  1  1/26 (3.85%)  0/10 (0.00%) 
Hepatobiliary disorders     
Hepatic lesion  1  1/26 (3.85%)  0/10 (0.00%) 
Infections and infestations     
Abscess limb  1  1/26 (3.85%)  0/10 (0.00%) 
Cellulitis  1  1/26 (3.85%)  0/10 (0.00%) 
Lower respiratory tract infection  1  1/26 (3.85%)  0/10 (0.00%) 
Sepsis  1  1/26 (3.85%)  0/10 (0.00%) 
Urinary tract infection  1  1/26 (3.85%)  0/10 (0.00%) 
Injury, poisoning and procedural complications     
Hepatic haematoma  1  0/26 (0.00%)  1/10 (10.00%) 
Wound complication  1  1/26 (3.85%)  0/10 (0.00%) 
Metabolism and nutrition disorders     
Hyperphosphataemia  1  1/26 (3.85%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  0/26 (0.00%)  1/10 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  1/26 (3.85%)  0/10 (0.00%) 
Metastases to central nervous system  1  1/26 (3.85%)  0/10 (0.00%) 
Metastases to liver  1  1/26 (3.85%)  0/10 (0.00%) 
Tumour haemorrhage  1  1/26 (3.85%)  0/10 (0.00%) 
Nervous system disorders     
Headache  1  0/26 (0.00%)  1/10 (10.00%) 
Renal and urinary disorders     
Renal failure  1  1/26 (3.85%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  1/26 (3.85%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: Afatinib Once Daily (OD). Part B: Afatinib+V (Vinorelbine).
Affected / at Risk (%) Affected / at Risk (%)
Total   26/26 (100.00%)   10/10 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  4/26 (15.38%)  5/10 (50.00%) 
Neutropenia  1  1/26 (3.85%)  8/10 (80.00%) 
Cardiac disorders     
Atrial flutter  1  0/26 (0.00%)  1/10 (10.00%) 
Eye disorders     
Dry eye  1  3/26 (11.54%)  0/10 (0.00%) 
Panophthalmitis  1  0/26 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/26 (0.00%)  2/10 (20.00%) 
Abdominal pain upper  1  2/26 (7.69%)  1/10 (10.00%) 
Diarrhoea  1  23/26 (88.46%)  6/10 (60.00%) 
Dry mouth  1  2/26 (7.69%)  0/10 (0.00%) 
Nausea  1  7/26 (26.92%)  5/10 (50.00%) 
Stomatitis  1  3/26 (11.54%)  1/10 (10.00%) 
Vomiting  1  7/26 (26.92%)  1/10 (10.00%) 
General disorders     
Catheter site erythema  1  0/26 (0.00%)  1/10 (10.00%) 
Fatigue  1  4/26 (15.38%)  5/10 (50.00%) 
Mucosal inflammation  1  10/26 (38.46%)  3/10 (30.00%) 
Pyrexia  1  1/26 (3.85%)  2/10 (20.00%) 
Infections and infestations     
Abscess limb  1  0/26 (0.00%)  1/10 (10.00%) 
Cellulitis  1  0/26 (0.00%)  1/10 (10.00%) 
Cystitis  1  1/26 (3.85%)  1/10 (10.00%) 
Eye infection  1  0/26 (0.00%)  1/10 (10.00%) 
Paronychia  1  9/26 (34.62%)  0/10 (0.00%) 
Rhinitis  1  0/26 (0.00%)  1/10 (10.00%) 
Upper respiratory tract infection  1  2/26 (7.69%)  2/10 (20.00%) 
Injury, poisoning and procedural complications     
Allergic transfusion reaction  1  0/26 (0.00%)  1/10 (10.00%) 
Contusion  1  0/26 (0.00%)  1/10 (10.00%) 
Fall  1  0/26 (0.00%)  1/10 (10.00%) 
Procedural haemorrhage  1  0/26 (0.00%)  1/10 (10.00%) 
Investigations     
Alanine aminotransferase increased  1  4/26 (15.38%)  0/10 (0.00%) 
Aspartate aminotransferase increased  1  4/26 (15.38%)  0/10 (0.00%) 
Blood alkaline phosphatase increased  1  2/26 (7.69%)  0/10 (0.00%) 
Blood creatine phosphokinase increased  1  0/26 (0.00%)  1/10 (10.00%) 
Neutrophil count decreased  1  0/26 (0.00%)  1/10 (10.00%) 
Weight decreased  1  7/26 (26.92%)  4/10 (40.00%) 
White blood cell count decreased  1  0/26 (0.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  10/26 (38.46%)  2/10 (20.00%) 
Hypokalaemia  1  5/26 (19.23%)  1/10 (10.00%) 
Hypomagnesaemia  1  2/26 (7.69%)  0/10 (0.00%) 
Hyponatraemia  1  0/26 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/26 (0.00%)  1/10 (10.00%) 
Muscle spasms  1  1/26 (3.85%)  1/10 (10.00%) 
Myalgia  1  1/26 (3.85%)  2/10 (20.00%) 
Pain in extremity  1  0/26 (0.00%)  1/10 (10.00%) 
Nervous system disorders     
Dizziness  1  2/26 (7.69%)  3/10 (30.00%) 
Headache  1  3/26 (11.54%)  1/10 (10.00%) 
Memory impairment  1  0/26 (0.00%)  1/10 (10.00%) 
Migraine  1  0/26 (0.00%)  1/10 (10.00%) 
Neuropathy peripheral  1  1/26 (3.85%)  1/10 (10.00%) 
Reproductive system and breast disorders     
Breast pain  1  2/26 (7.69%)  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  0/26 (0.00%)  1/10 (10.00%) 
Dyspnoea  1  0/26 (0.00%)  2/10 (20.00%) 
Epistaxis  1  4/26 (15.38%)  0/10 (0.00%) 
Oropharyngeal pain  1  0/26 (0.00%)  1/10 (10.00%) 
Pleural effusion  1  0/26 (0.00%)  1/10 (10.00%) 
Rhinorrhoea  1  0/26 (0.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  0/26 (0.00%)  1/10 (10.00%) 
Dermatitis  1  1/26 (3.85%)  1/10 (10.00%) 
Dermatitis acneiform  1  5/26 (19.23%)  0/10 (0.00%) 
Dry skin  1  2/26 (7.69%)  1/10 (10.00%) 
Erythema  1  3/26 (11.54%)  1/10 (10.00%) 
Fungating wound  1  0/26 (0.00%)  1/10 (10.00%) 
Hand dermatitis  1  0/26 (0.00%)  1/10 (10.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  3/26 (11.54%)  1/10 (10.00%) 
Pruritus  1  2/26 (7.69%)  0/10 (0.00%) 
Rash  1  17/26 (65.38%)  1/10 (10.00%) 
Skin lesion  1  2/26 (7.69%)  0/10 (0.00%) 
Vascular disorders     
Lymphoedema  1  1/26 (3.85%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Boehringer Ingelheim (BI) decided to stop further inclusion of patients and stop further treatment with the combination of Afatinib and Vinorelbine as of 03-May-2013. Recruitment into the trial was stopped by amendment in Jul 2013.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim (BI)
Phone: 1800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01325428     History of Changes
Other Study ID Numbers: 1200.89
2010-024454-10 ( EudraCT Number: EudraCT )
First Submitted: March 28, 2011
First Posted: March 29, 2011
Results First Submitted: November 17, 2015
Results First Posted: February 11, 2016
Last Update Posted: July 19, 2016