Trial Outcomes & Findings for Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients (NCT NCT00730925)
NCT ID: NCT00730925
Last Updated: 2014-03-26
Results Overview
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
Results posted on
2014-03-26
Participant Flow
Participant milestones
| Measure |
Afatinib 50mg
Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Afatinib 50mg
Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Overall Study
Progressive Disease
|
21
|
|
Overall Study
Dose reducing Event
|
2
|
|
Overall Study
Other Averse Event
|
7
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Switch to combination therapy
|
8
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients
Baseline characteristics by cohort
| Measure |
Afatinib 50mg
n=41 Participants
Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.Population: Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
Outcome measures
| Measure |
Afatinib 50mg
n=41 Participants
Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Percentage of Participants With Best Objective Response
|
2 Percentage of participants
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.Population: Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
Percentage of participants with OR or stable disease (SD) as determined by RECIST version 1.0.
Outcome measures
| Measure |
Afatinib 50mg
n=41 Participants
Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Percentage of Participants With Disease Control (DC)
|
59 Percentage of participants
Interval 42.0 to 74.0
|
SECONDARY outcome
Timeframe: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.Population: Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
PFS time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.
Outcome measures
| Measure |
Afatinib 50mg
n=41 Participants
Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Progression Free Survival (PFS) Time
|
15.86 Weeks
Interval 8.14 to 19.14
|
SECONDARY outcome
Timeframe: Day 15, 29 and 57Population: Patients with no data available for the relevant parameter and dose were excluded from analysis.
Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 15, 29 and 57 (Cpre,ss,15, Cpre,ss,29 and Cpre,ss,57)
Outcome measures
| Measure |
Afatinib 50mg
n=30 Participants
Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Summary of Pre-dose Concentrations of Afatnib in Plasma
Cpre,ss,15 (N=13)
|
35.0 ng/mL
Geometric Coefficient of Variation 74.9
|
|
Summary of Pre-dose Concentrations of Afatnib in Plasma
Cpre,ss,29 (N=12)
|
22.6 ng/mL
Geometric Coefficient of Variation 79.5
|
|
Summary of Pre-dose Concentrations of Afatnib in Plasma
Cpre,ss,57 (N=5)
|
27.9 ng/mL
Geometric Coefficient of Variation 96.1
|
Adverse Events
Afatinib 50mg
Serious events: 19 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib 50mg
n=41 participants at risk
Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Disease progression
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
General physical health deterioration
|
9.8%
4/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Pyrexia
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Spinal pain
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Bacterial infection
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Clostridium colitis
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Gastroenteritis
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Pneumonia klebsiella
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Urosepsis
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Epilepsy
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Renal failure
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.9%
2/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/41 • First administration of trial medication until 28 days after last administration of trial medication
|
Other adverse events
| Measure |
Afatinib 50mg
n=41 participants at risk
Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Eye disorders
Blepharitis
|
12.2%
5/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Eye disorders
Conjunctivitis
|
14.6%
6/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Abdominal pain
|
9.8%
4/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Constipation
|
19.5%
8/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Diarrhoea
|
87.8%
36/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Nausea
|
26.8%
11/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Stomatitis
|
26.8%
11/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Vomiting
|
29.3%
12/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Asthenia
|
29.3%
12/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Chest pain
|
12.2%
5/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Fatigue
|
24.4%
10/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Mucosal inflammation
|
17.1%
7/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Oedema peripheral
|
9.8%
4/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Pain
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Pyrexia
|
17.1%
7/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Bronchitis
|
9.8%
4/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Nasopharyngitis
|
14.6%
6/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Paronychia
|
19.5%
8/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Urinary tract infection
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
53.7%
22/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.8%
4/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Dysgeusia
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.7%
13/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.8%
11/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.5%
8/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Acne
|
24.4%
10/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.2%
5/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.2%
5/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.8%
4/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
7.3%
3/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
12.2%
5/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
9.8%
4/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.5%
8/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
68.3%
28/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
12.2%
5/41 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
12.2%
5/41 • First administration of trial medication until 28 days after last administration of trial medication
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER