Status:
COMPLETED
Dose-finding Study of BP-C1 in Patients With Stage IV Breast Cancer
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:
PHASE1
Brief Summary
The purpose of this study is to estimate the cumulative Maximum Tolerated Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in the short-term treatment of metastatic breast cancer patients.
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 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
- 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 haematology status defined by haemoglobin \< 9.0 g/dL, platelet count \< 100,000/mm\^3 or leucocytes \< 3x10\^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.
Key Trial Info
Start Date :
June 27 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04298333
Start Date
June 27 2009
End Date
January 4 2011
Last Update
March 6 2020
Active Locations (3)
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1
Sanglah University Hospital
Bali, Indonesia
2
National Taiwan University Hospital
Taipei, Taiwan
3
Siriraj Hospital, Mahidol University
Bangkok, Thailand