A randomized, open label, Phase II Proof of Concept study of WX-671 in combination with gemcitabine vs gemcitabine alone in patients with locally advanced, non-resectable pancreatic cancer in order to evaluate the anti-tumor activity of the combination therapy. - ND

• Conditions: ocally advanced, non-resectable pancreatic cancer; MedDRA version: 12.0Level: LLTClassification code 10052747Term: Adenocarcinoma pancreas

• Registration Number: EUCTR2006-005314-12-IT
• Lead Sponsor: WILEX AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Locally advanced, unresectable, non-metastatic, histologically proven pancreatic adenocarcinoma (lymph nodes will not be considered 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 ≥ 1.5x109/L
platelets ≥ 100 x109/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 patients 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 lifethreatening 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Exploratory proof of concept study to assess the anti-tumor activity of two different doses of WX-671 when given in combination with gemcitabine.;Secondary Objective: Safety and Pharmacokinetics.<br>The following safety and tolerability variables will be measured<br>i. Vital signs<br>ii. ECG<br>iii. Biochemistry<br>iv. Hematology (including coagulation)<br>v. Adverse events;Primary end point(s): A number of variables will be explored to identify those whose effect may demonstrate activity of the combination of WX-671 and gemcitabine.<br>The following efficacy variables will be measured:<br>i. Response rate<br>ii. Progression free survival<br>iii. Time to first metastasis<br>iv. Overall survival<br>v. Tumor and uPA system related marker