Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 … (NCT00748709) | Clinical Trial Compass
TerminatedPhase 2
Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.
United States20 participantsStarted 2008-10-01
Plain-language summary
This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed diagnosis of advanced cancer of one of the following four tumor type categories:
✓. Measurable disease by RECIST criteria.
✓. Willingness and ability to give written informed consents consistent with ICHGCP guidelines.
✓. Life expectancy of at least three (3) months.
✓. Eastern Cooperative Oncology Group performance score 0, 1 or 2.
✓. Age \>18 years.
✓. Histologically confirmed diagnosis of advanced cancer of one of the following four tumor type categories:
✓. Documented failure to respond or progression of underlying cancer after at least one line of prior chemotherapy.
Exclusion criteria
✕. Prior treatment with gefitinib, erlotinib, lapatinib and/or other EGFR TKIs.
✕. Treatment with cytotoxic anti-cancer-therapies or investigational drugs during the last four weeks prior to the first treatment with the trial drug. (a shorter duration may be considered for patients treated with oral, non cytotoxic drugs on an individual basis and upon discussion between the principal investigator and sponsor)
✕. Inability to take BIBW 2992 by mouth (BIBW 2992 may not be crushed or administered via Gastrostomy-tube)
✕
What they're measuring
1
Percentage of Participants With Objective Response (OR)
Timeframe: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter
. Chronic diarrhea or other gastrointestinal disorders that may interfere with the absorption of the trial drug.
✕. History of other malignancies unless free of disease for at least 3 years (except for appropriately treated superficial non-melanoma skin cancer and surgically cured cervical cancer in situ).
✕. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
✕. Resting left ventricular ejection fraction \<50% OR below the institution's lower limit of normal (if the institutions lower limit is above 50%), measured by MUGA scan or echocardiogram.