Overview

BP-C1 in Short-term Treatment of Patients With Metastatic Breast Cancer

Status:
Completed
Trial end date:
2014-02-28
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to determine whether BP-C1 is effective in the treatment of metastatic breast cancer patients who had previously received at least three lines of chemotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Meabco A/S
Collaborators:
Meddoc
Meddoc AS
Norwegian University of Life Sciences
Criteria
Inclusion Criteria:

Female patients with histologically verified metastatic breast cancer (stage IV) with
measurable metastases, between 18 and 80 years of age, who had undergone at least three
lines of chemotherapy and 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 >34 μmol/L or ALAT > 3 times of
the upper limit of normal (ULN). In case of metastases in the liver, the ALAT limit
for exclusion is set to 5хULN.

- Abnormal kidney function defined by serum creatinine >120 μmol/L.

- Abnormal coagulation capacity defined by the relative arbitrary concentration of
coagulation factors 2,7,10; INR >1.5.

- Verified metastases to the brain.

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

- Abnormal hematology status defined by hemoglobin < 9.0 g/dL, platelet count <
100,000/mm^3 or leucocytes < 3 x 10^9/L.

- Clinically significant abnormal ECG.

- Karnofsky performance status score <60%.

- Pregnant or breast feeding women.

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

- Fertile female who do not want to use safe protection against pregnancy, starting one
month before the start of the study treatment and lasting at least six weeks after.

- 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.