BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2016-03-04
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the short-term effect and tolerability BP-C1 in patients with metastatic pancreatic cancer who has undergone guideline-recommended chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meabco A/S
• Collaborators: Meddoc; Meddoc AS; Norwegian University of Life Sciences
• Treatments: Molybdenum

Criteria

Inclusion Criteria:

• Patients of all genders between 18 and 80 years of age with metastatic pancreatic cancer (unresectable pancreatic cancer with increased levels of cancer antigen 19-9), who had an expected survival time of at least 3 months.

Exclusion Criteria:

Patients fulfilling at least one of the following criteria will be excluded from participation in the study:

• Abnormal liver function classified as total bilirubin >136 μmol/L (8.0 mg/dL)

• Abnormal kidney function defined by serum creatinine >120 μmol/L (1.5 mg/dL).

• Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10 < 0.7 or international normalized ratio >1.5.

• Verified metastases to the brain.

• Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.

• Abnormal haematology status defined by hemoglobin < 6.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3 x 10^9/L.

• Clinically significant abnormal ECG.

• Karnofsky performance status score <60%.

• Pregnancy or breast-feeding.

• Women of fertile age who do not want to be tested for possible pregnancy.

• Uncontrolled bacterial, viral, fungal or parasite infection.

• Under systemic treatment with corticosteroids or other immunosuppressive drugs in the last 21 days before start of the trial treatment.

• Participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment.

• Not able to understand information.

• Not willing or not able to give written consent to participate in the study.