EUCTR2006-005314-12-ESActive, not recruitingNot Applicable
A randomised, open label, Phase II Proof of Concept study of WX-671 in combination with gemcitabine vs gemcitabine in patients with locally advanced, non-resectable pancreatic cancer in order to evaluate the anti-tumor activity of the combination therapyEstudio de prueba de concepto en fase II, aleatorizado, abierto de WX-671 en combinación con gemcitabina frente a gemcitabina sola en pacientes con cáncer de páncreas localmente avanzado no resecable cuyo objetivo es evaluar la actividad antitumoral de la terapia en combinación
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Wilex AG
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Locally advanced, unresectable, non-metastatic, histologically proven pancreatic adenocarcinoma (lymph nodes will not be considered as metastases)
- •2. Male or female subjects age >= 18 years
- •3. ECOG performance status <= 1
- •4. Life expectancy > 12 weeks
- •5. Signed and dated informed consent form
- •6. Patient able to participate, communicate well with the investigator and willing to give informed consent and comply with the study restrictions
- •7. Normal 12-lead ECG or only clinically insignificant abnormalities in the judgment of the investigator
- •8. Female patients of child-bearing potential will be required to use an effective method of birth control for the duration of the study to prevent pregnancy. Acceptable methods include implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or sterilization (including vasectomy of partner).
- •9. Laboratory parameters (obtained within the screening period):
- •- neutrophils >= 1.5x10 9/L
- •- platelets >= 100 x10 9/L
- •- Hgb >= 9 g/dL)
- •- total bilirubin <= 1.5 x ULN
- •- ASAT/ALAT/AP <= 2.5 x ULN
- •- serum creatinine <= 2 x ULN (calculated creatinine clearance > 45 ml/min)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Any distant metastases
- •2. History of or current primary blood coagulation or bleeding disorders such as hemophilia
- •3. Anticoagulant or thrombolytic therapy within four weeks prior to start of treatment (except low dose anticoagulant therapy with unfractionated heparin <= 15000 IU/d, low molecular weight heparin <= 5000 IE anti-Xa activity or acetyl salicylic acid <= 100 mg/d at the discretion of the investigator)
- •4. Any unrelated illness, e.g., active infection, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect the patient’s study participation
- •5. Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug
- •6. Significant cardiac insufficiency (NYHA classification III or IV), presence of unstable angina or myocardial infarction within the previous 6 months, use of ongoing maintenance therapy for life-threatening arrhythmia or known pulmonary hypertension
- •7. Any secondary malignancies within the last 5 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ
- •8. Pregnancy (positive serum pregnancy test) or lactation
- •9. Known Hepatitis B/C or HIV infection
- •10. Known hypersensitivity to any of the components in the WX-671 capsules or gemcitabine infusion or other medical reasons for not being able to receive adequate pre-medication (for example, antihistamine or anti-inflammatory agents)
Investigators
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