Trial Outcomes & Findings for Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification. (NCT NCT00748709)
NCT ID: NCT00748709
Last Updated: 2025-02-11
Results Overview
OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter
Results posted on
2025-02-11
Participant Flow
"The trial was terminated earlier than planned because of a high screen-failure rate and recruitment challenges that prevented full accrual; no safety or efficacy findings influenced this decision. "
Participant milestones
| Measure |
Afatinib 50mg
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Afatinib 50mg
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Overall Study
Progressive disease
|
15
|
|
Overall Study
Drug reducing Toxity
|
2
|
|
Overall Study
Other Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Other Reasons
|
1
|
Baseline Characteristics
Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.
Baseline characteristics by cohort
| Measure |
Afatinib 50mg
n=20 Participants
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafterPopulation: Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.
OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).
Outcome measures
| Measure |
Afatinib 50mg
n=20 Participants
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Percentage of Participants With Objective Response (OR)
|
5.0 percentage of patients
|
SECONDARY outcome
Timeframe: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lockPopulation: TS.
CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST 1.0 criteria.
Outcome measures
| Measure |
Afatinib 50mg
n=20 Participants
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Percentage of Participants With Clinical Benefit (CB)
With CB
|
45.0 percentage of patients
|
|
Percentage of Participants With Clinical Benefit (CB)
Without CB
|
55.0 percentage of patients
|
SECONDARY outcome
Timeframe: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lockPopulation: Trial terminated early, therefore no data summaries produced for time to OR.
The time to 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 1.0 criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.Population: Trial terminated early, therefore no data summaries produced for duration of OR.
Duration 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
SECONDARY outcome
Timeframe: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.Population: Trial terminated early, therefore no data summaries produced for PFS.
PFS was defined as the time from the start of treatment to the occurrence of disease progression or death, whichever came first. Disease progression was assessed according to RECIST 1.0 criteria as well as by the investigators assessment, progression date recorded from post trial follow up or start of new anticancer treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First administration of trial medication until 28 days after last administration of trial medicationPopulation: TS
Patients with adverse events (AEs) resulting in dose reduction or treatment discontinuation
Outcome measures
| Measure |
Afatinib 50mg
n=20 Participants
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation
With AE leading to drug discontinuation
|
5 Participants
|
|
Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation
With AE leading to dose reduction
|
1 Participants
|
|
Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation
With Treatment held or paused due to AE
|
8 Participants
|
SECONDARY outcome
Timeframe: First administration of trial medication until 28 days after last administration of trial medicationPopulation: TS
Patients with AEs by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade
Outcome measures
| Measure |
Afatinib 50mg
n=20 Participants
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Maximum CTCAE Grade
Grade 5
|
3 Participants
|
|
Maximum CTCAE Grade
Grade 1
|
2 Participants
|
|
Maximum CTCAE Grade
Grade 2
|
5 Participants
|
|
Maximum CTCAE Grade
Grade 3
|
10 Participants
|
|
Maximum CTCAE Grade
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 15Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15 for patients on 50mg on day 15.
Outcome measures
| Measure |
Afatinib 50mg
n=12 Participants
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) for Patients on 50mg on Day 15
|
33.2 ng/mL
Geometric Coefficient of Variation 80.0
|
SECONDARY outcome
Timeframe: First administration of trial medication until 28 days after last administration of trial medicationPopulation: TS
Number of Patients with Diarrhea or Rash
Outcome measures
| Measure |
Afatinib 50mg
n=20 Participants
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Number of Patients With Diarrhea or Rash
AE : Diarrhea
|
18 Participants
|
|
Number of Patients With Diarrhea or Rash
AE : Rash
|
12 Participants
|
Adverse Events
Afatinib 50mg
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib 50mg
n=20 participants at risk
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Escherichia bacteraemia
|
5.0%
1/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • 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
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
5.0%
1/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • First administration of trial medication until 28 days after last administration of trial medication
|
Other adverse events
| Measure |
Afatinib 50mg
n=20 participants at risk
Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
4/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Diarrhoea
|
85.0%
17/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
4/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
7/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Chest pain
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Fatigue
|
45.0%
9/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Oedema peripheral
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Paronychia
|
30.0%
6/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Urinary tract infection
|
20.0%
4/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood creatinine increased
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Weight decreased
|
20.0%
4/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
55.0%
11/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
4/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
15.0%
3/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Dysgeusia
|
15.0%
3/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Haematuria
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
4/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
2/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
30.0%
6/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
4/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
4/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
60.0%
12/20 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • 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
- Publication restrictions are in place
Restriction type: OTHER