BP-C1 Monotherapy in Patients With Metastatic Breast Cancer Cancer: Estimation of Optimal Duration of Treatment

• Status: Completed
• Trial end date: 2016-07-29
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to establish an optimal treatment duration and tolerable cumulative dose for BP-C1 in the treatment of metastatic breast cancer patients who had previously undergone at least three lines of chemotherapy.

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

Details

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

Criteria

Inclusion Criteria:

Female patients who have completed 32-day treatment with BP-C1 (under protocols BMC2011-1, MBC-BPC1/IIA, BMC2012-4), having increase in toxicity not above moderate level, and having no progression of the disease. In accordance with inclusion criteria checked in the studies BMC2011-1, MBC-BPC1/IIA, or BMC2012-4, the patients are between 18 and 80 years with metastatic breast cancer (stage IV), had previously underwent at least third line chemotherapy, and have an expected survival time of at least 3 months.

Exclusion Criteria:

• Severe or life-threatening increase in toxicity after preceding 32-day treatment with BP-C1.

• 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 <0.70 or international normalised ratio (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 3 weeks 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.