A Randomized, Double-Blind, Two-Way Crossover, Bioequivalence Study of SID530 and Taxotere® in Study Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Platinum Therapy Failure or Study Participants With Locally Advanced or Metastatic Breast Cancer Who Have Failed At Least One Prior Chemotherapeutic Regimen
Study participants who meet eligibility criteria will be randomized to one of two treatment
sequences (i.e., SID530 on Day 1 followed by Taxotere on Day 21 or Taxotere on Day 1
followed by SID530 on Day 21). Randomization will be stratified by whether the study
participant received prior docetaxel treatment.
All study participants will be premedicated with oral dexamethasone, 16 mg per day (e.g. 8
mg b.i.d.) for three days, starting one day prior to each study drug infusion, in order to
reduce the incidence and severity of fluid retention as well as the severity of
hypersensitivity reactions. During each treatment cycle, both the test and the reference
treatments will receive identical dosages of docetaxel (i.e., 75 mg/m2, by i.v. infusion,
over 1 hour).
Study completion will be defined as completing all protocol-specified procedures. Study
participants who are prematurely withdrawn from the study will be requested to complete the
assessments conducted at the Final Visit.
Blood samples for pharmacokinetic analysis will be obtained at the predefined times during
Cycle 1 and Cycle 2.
Adverse events will be assessed throughout the study, including 21 days after the last study
drug infusion. Hematology assessments,other laboratory parameters and vital signs will be
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
to test the bioequivalence of SID530 (test) to Taxotere
United States: Food and Drug Administration
|Gabrail Cancer Center||Canton, Ohio 44718|
|Advanced Clinical Research Pharma||Miami, Florida|