Trial Outcomes & Findings for A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR] (NCT NCT01003899)
NCT ID: NCT01003899
Last Updated: 2013-12-31
Results Overview
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Baseline till progression or death
Results posted on
2013-12-31
Participant Flow
Participant milestones
| Measure |
Afatinib 40 mg
Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
Afatinib 40 mg
Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
|
|---|---|
|
Overall Study
Other Adverse Event
|
8
|
|
Overall Study
Not entered
|
4
|
|
Overall Study
Not treated
|
1
|
|
Overall Study
Progressive disease
|
34
|
Baseline Characteristics
A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]
Baseline characteristics by cohort
| Measure |
Afatinib 40 mg
n=42 Participants
Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
|
|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline till progression or deathPopulation: FAS (Full Analysis Set). The FAS consisted of all treated patients, excluding any patients found not be EGFR mutation negative according to central laboratory testing.
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).
Outcome measures
| Measure |
Afatinib 40 mg
n=38 Participants
Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
|
|---|---|
|
Percentage of Participants With Best Objective Response
|
0 Percentage of participants
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Baseline till progression or deathPopulation: FAS - Full Analysis Set
Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.
Outcome measures
| Measure |
Afatinib 40 mg
n=38 Participants
Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
|
|---|---|
|
Percentage of Participants With Disease Control (DC)
|
24 Percentage of participants
Interval 11.0 to 40.0
|
SECONDARY outcome
Timeframe: Baseline till end of study or deathPopulation: FAS - Full Analysis Set
PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death
Outcome measures
| Measure |
Afatinib 40 mg
n=38 Participants
Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
|
|---|---|
|
Progression Free Survival (PFS) Time
|
4.07 Weeks
95% Confidence Interval (11, 40) • Interval 3.86 to 8.0
|
SECONDARY outcome
Timeframe: Baseline till progression or deathPopulation: FAS - Full Analysis Set
Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).
Outcome measures
| Measure |
Afatinib 40 mg
n=9 Participants
Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
|
|---|---|
|
Duration of Disease Control (DC)
|
19.29 weeks
Interval 11.6 to 43.1
|
SECONDARY outcome
Timeframe: Baseline till progression or deathThe time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline till progression or deathDuration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
Outcome measures
Outcome data not reported
Adverse Events
Afatinib 40 mg
Serious events: 17 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib 40 mg
n=42 participants at risk
Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.8%
2/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Melaena
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Pyrexia
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Pneumonia
|
11.9%
5/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood creatinine increased
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
2/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
1/42 • First administration of trial medication until 28 days after last administration of trial medication
|
Other adverse events
| Measure |
Afatinib 40 mg
n=42 participants at risk
Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
4/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Constipation
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Diarrhoea
|
61.9%
26/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Nausea
|
19.0%
8/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Stomatitis
|
35.7%
15/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Asthenia
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Chest discomfort
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Chest pain
|
11.9%
5/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Fatigue
|
9.5%
4/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Mucosal inflammation
|
28.6%
12/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Pyrexia
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Paronychia
|
31.0%
13/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Weight decreased
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
18/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
4/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
4/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Headache
|
9.5%
4/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
9/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.5%
4/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.5%
4/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Acne
|
21.4%
9/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
7/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
7.1%
3/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.0%
13/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
76.2%
32/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
14.3%
6/42 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
11.9%
5/42 • 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