Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT01728818
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01728818
Study Brief:
Protocol Section:
NCT01728818