Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
PD Dr. med. Volker Heinemann
With
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent in advance of any study-specific procedure
Histologically (not cytologically) confirmed diagnosis of metastatic pancreatic adenocarcinoma (stage IV according to UICC 2009 classification: each T, each N, M1)
Availability of tumour samples
Informed consent that tumour- and blood samples are centrally collected and will serve for translational analyses according to the study protocol.
Age \>= 18 years
ECOG 0-1
Life expectancy at least 3 months
No option for surgical resection or radiation in curative intent
At least one measurable tumour lesion (CT-scan or MRI) according to RECIST Version 1.1
Possibility of long-term follow-up
Negative pregnancy test in fertile females
Given legal capacity of the patient
Adequate hepatic, renal and bone marrow function
You may not be if
Evidence of weight loss \> 15% within one month
Active brain metastases (stable for \<28 days, symptomatic, or requiring concurrent steroids) or leptomeningeal disease. Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded
Previous gemcitabine treatment is allowed only if applied as monotherapy in the adjuvant setting and if the adjuvant single-agent gemcitabine chemotherapy was terminated at least 6 months before study entry
Previous systemic treatment with chemotherapy or radiotherapy for locally advanced, non resectable or metastatic pancreatic cancer
Radiotherapy within four weeks prior to randomization or radiation of target lesions
Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past 4 weeks before start of therapy or concomitantly with this trial
Hypersensitivity to afatinib or to gemcitabine or to any of the excipients or to compounds with similar chemical or biologic composition
Contraindications against the use of gemcitabine
Severe renal insufficiency (baseline creatinine clearance \< 30 ml/mi)
LDH elevated by \> 2.5 ULN
Severe hepatic dysfunction
Any disease e. g. active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA (\<= 6 months before study start), myocardial infarction (\<= 6 months before study start), unstable angina, NYHA \>= grade 2 CHF, arrhythmia requiring medication, metabolic dysfunction giving reasonable suspicion of a disease or condition that contra-indicates the use of the study drugs or puts the patient at high risk for treatment-related complications
Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption or CTC grade \> 2 diarrhoea of any aetiology
Pregnant or lactating females, non-effective contraception in men and women of childbearing potential (an effective contraceptive measure has a Pearl Index \< 1)
Any major surgery within the last 2 weeks before study entry
Chemo- or immunotherapy within the past 4 weeks
Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
Any persisting toxicities which are deemed to be clinically significant from the previous therapy
Patients with pre-existing interstitital lung disease
Psychological, familial, social or geographic conditions that may prevent an adequate compliance with the study protocol
Known or suspected alcohol- or drug abuse
Patients unable to comply with the protocol
Known hepatitis B infection, known hepatitis C infection or HIV carrier
Requirement for treatment with any of the prohibited concomitant medications
Any other malignancies within the last 5 years before study start, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer
Clareo Health | Afatinib as Cancer Therapy for Exocrine Pancreatic Tumours
