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).
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Maximum Observed Plasma Concentration (Cmax)
Day -1, Day 1, Day 8, Day 16, Day 24, Day 32
Shani Paluch-Shimon, Dr.
Sheba Medical Centre, Ramat-Gan, Israel.
Israel: Ministry of Health