Status:
COMPLETED
BP-C1 in Metastatic Breast Cancer Patients
Lead Sponsor:
Meabco A/S
Conditions:
Metastatic Breast Cancer
Stage IV Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE1
Brief Summary
This study is an open label, non-randomized phase I single-armed study in women with metastatic breast cancer (MBC) who have previously undergone all available standard chemotherapy regimens. The purp...
Detailed Description
BP-C1, solution for injections 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 pl...
Eligibility Criteria
Inclusion
- Female patients with metastatic breast cancer (MBC, stage IV).
- 18 and 80 years of age.
- Measurable lesions / lymph nodes.
- Have previously undergone at least third line chemotherapy.
- Expected survival time at least 3 months.
Exclusion
- Abnormal liver function classified as total bilirubin \>34 μmol/L or ALAT \> 3 times the upper limit of normal range (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5xULN. Re-test results of blood samples taken again up to 2 days before Day-1 must keep meeting eligibility criteria.
- Abnormal kidney function defined by serum creatinine \>120 μmol/L. Re-test results of blood samples taken again up to 2 days before Day-1 must keep meeting eligibility criteria.
- Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10 INR \>1.3. Re-test results of blood samples taken again up to 2 days before Day-1 must keep meeting eligibility criteria.
- Brain metastases in symptomatic patients requiring ≥4 mg dexamethasone/day. However, patients with treated brain metastases by surgery or radiation who are stable and symptom-free (\<4 mg dexamethasone/day) for a minimum period of 4 weeks prior to study treatment are eligible.
- Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
- Abnormal haematology status defined by Hb \< 9.0 g/dL, platelet count \< 75,000/mm\^3 and leukocytes \< 3x10\^9/L. Re-test results of blood samples taken again up to 2 days before Day-1 must keep meeting eligibility criteria.
- Clinically significant abnormal ECG.
- Karnofsky Performance Status Score \< 50%.
- 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 start of the trial treatment and lasting at least six weeks after.
- Uncontrolled bacterial, viral, fungal or parasite infection.
- Under systemic treatment with corticosteroids or other immunosuppressive drugs during the last 21 days before start of the trial treatment. Systemic treatment with \<4 mg dexamethasone/day is allowed
- Participating in another clinical trial with pharmaceuticals during the last six weeks before start of this trial treatment.
- Not able to understand written or oral information.
- Do not want or is not able to give written consent to participate in the study.
Key Trial Info
Start Date :
January 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01861509
Start Date
January 19 2014
End Date
January 20 2016
Last Update
October 7 2019
Active Locations (2)
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1
Oncology Unit. Sheba Medical Centre
Ramat Gan, Israel, 52621
2
Lampang Cancer Center
Lampang, Thailand, 52000