Pharmacokinetic, Pharmacodynamic and Interleukin Profile of Intramuscularly Administered BP-C1 in Women With Metastatic Breast Cancer: A Phase I(D) Study
18 Years
80 Years
Female
Metastatic Breast Cancer
Trial Information
Pharmacokinetic, Pharmacodynamic and Interleukin Profile of Intramuscularly Administered BP-C1 in Women With Metastatic Breast Cancer: A Phase I(D) Study
All six MBC patients will be recruited from the single participating site. Each included
patient will participate in a screening period of maximum 21 days + 32 days treatment period
+ 28 days follow-up period. If no further treatment is indicated beyond 32 days as per the
principal investigator, the maximum duration for one patient will then be 81 days.
The patients will be treated continuously in 32 days with one intramuscular (IM) injection
of 0.035 mg/kg bodyweight (0.07 ml/Kg) of BP-C1 daily. This represents a cumulative dose of
1.12 mg/kg bodyweight (2.24 ml/kg).
Inclusion Criteria:
- Female MBC patients classified as stage IV
- 18 and 80 years of age
- Measurable lesions / lymph node
- Have previously undergone all available standard chemotherapy
- Expected survival time exceeding 3 months
Exclusion Criteria:
- Known breast cancer susceptibility gene(BRCA) 1/2 positive tumor suppressor gene
mutation
- Abnormal liver function classified as total Bilirubin >34 micromol/l or alanine
aminotransferase(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 5 x ULN.
- Abnormal kidney function defined by serum creatinine >120 micromol/l.
- Abnormal coagulation capacity defined by the relative arbitrary concentration of
coagulation factors 2,7,10 international normalized ratio(INR) >1.3
- Patients with verified metastasis to the brain
- Synchronous cancer except for non-melanoma skin cancer and early stage of cervical
cancer
- Abnormal haematology status defined by Hgb < 9.0 gr/dl, platelet count < 100.000/mm3
and leucocytes < 3 x 109/l
- Clinical significant abnormal ECG
- Karnofsky 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 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.
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Maximum Observed Plasma Concentration (Cmax)
Outcome Time Frame:
Day -1, Day 1, Day 8, Day 16, Day 24, Day 32
Safety Issue:
No
Principal Investigator
Shani Paluch-Shimon, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sheba Medical Centre, Ramat-Gan, Israel.
Authority:
Israel: Ministry of Health
Study ID:
BMC 2012-4
NCT ID:
NCT01861509
Start Date:
June 2013
Completion Date:
March 2014
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms
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