Status:
COMPLETED
BP-C1 Monotherapy in Patients With Metastatic Breast Cancer Cancer: Estimation of Optimal Duration of Treatment
Lead Sponsor:
Meabco A/S
Collaborating Sponsors:
Meddoc
Norwegian University of Life Sciences
Conditions:
Metastatic Breast Cancer
Stage IV Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief 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 le...
Detailed Description
BP-C1, solution for injection 0.05%, is currently being developed for treatment of patients with metastatic breast cancer with palliative intent. Active substance of the product, which is a novel plat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03789019
Start Date
February 22 2013
End Date
July 29 2016
Last Update
October 10 2019
Active Locations (7)
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1
Russian Oncological Research Centre n.a. N.N. Blokhin, Russian Academy of Medical Science (RAMS)
Moscow, Russia
2
Leningrad Regional Oncological Centre
Saint Petersburg, Russia
3
St. Petersburg State Budgetary Health Organization, City Clinical Oncology Dispensary
Saint Petersburg, Russia
4
Siriraj Hospital, Mahidol University
Bangkok, Thailand