Locally advanced, non-resectable pancreatic adenocarcinoma MedDRA version: 8.1 Level: LLT Classification code 10033604 Term: Pancreatic cancer
Conditions
Interventions
WX-671.1 (hydrogen sulphate)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Gemzar
Pharmaceutical Form: Powder for injection*
INN or Proposed INN
Sponsors
Wilex AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Locally advanced, unresectable, non-metastatic, histologically or cytologically proven pancreatic adenocarcinoma (locoregional lymph nodes will not be considered metastases). No prior cancer related surgical intervention except for exploratory or palliative surgery is allowed. 2. No prior chemo- or radiotherapy, investigational, endocrine or biological therapy 3. Male or female subjects age >= 18 years 4. ECOG performance status 12 weeks 6. Signed and dated informed consent form 7. Patient able to participate, communicate well with the investigator and willing to give informed consent and comply with the study restrictions 8. Normal 12-lead ECG or only clinically insignificant abnormalities in the judgment of the investigator 9. 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). 10. Laboratory parameters (obtained within the screening period): - neutrophils >= 1.5x10 9/L - platelets >= 100 x10 9/L - Hgb >= 9 g/dL) - total bilirubin 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate Progression free survival Time to first metastasis Overall survival Tumor and uPA system related marker ;Secondary Objective: Safety Pharmacokinetics;Primary end point(s): Response rate Progression free survival Time to first metastasis Overall survival Tumor and uPA system related marker | — |
Countries
Germany, Hungary, Italy, Spain
Outcome results
None listed