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
18 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
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participants who are prematurely withdrawn from the study will be requested to complete the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
assessed.
Inclusion Criteria:
Study participants- Has provided written informed consent
- Is at least 18 years of age
- Has histologically or cytologically confirmed non-small cell lung (NSCLC) or breast
cancer (BC) that is locally advanced or metastatic
- Has at least two planned consecutive 21-day cycles with 75 mg/m2 docetaxel
monotherapy
- Has a life expectancy of at least 3 months
- Has Eastern Cooperative Oncology Group Performance Scale (ECOG PS) is in the range
of 0-2 at the time of randomization
- Has the Proper laboratory values within 1 week prior to randomization
- Has negative serum pregnancy test within 1 week before first study drug
administration (for women of childbearing potential, only)
- Is willing to practice medically accepted contraception (if the risk of conception
exists) throughout the study period (from Screening until the Final Visit)
Exclusion Criteria:Study participants
- Has had any chemotherapy within 4 weeks before date of first study treatment
- Has experienced severe side effects from (or severe hypersensitivity to) prior
docetaxel treatment (or other drugs formulated with polysorbate 80,
hydroxypropylbetadex, or povidone) such that discontinuation of the treatment was
required
- Has a history of hypersensitivity to dexamethasone
- Is pregnant, lactating, or breastfeeding
- Is taking one or more compounds that induce, inhibit, or are metabolized by
cytochrome P450 3A4
- Has had treatment in another clinical study within the past 30 days
- Has medical or psychological conditions that would not permit the study participant
to complete the study or sign informed consent
- Is unlikely to comply with the protocol requirements, instructions and study-related
restrictions
- Has any other disease, dysfunction (including alcohol or drug abuse), physical
examination or laboratory finding which, in the investigator's opinion, would exclude
the participant from the study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Outcome Measure:
to test the bioequivalence of SID530 (test) to Taxotere
Outcome Time Frame:
7 weeks
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
SID530_2009
NCT ID:
NCT00931008
Start Date:
October 2009
Completion Date:
January 2011
Related Keywords:
- Non-Small Cell Lung Cancer
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Gabrail Cancer Center | Canton, Ohio 44718 |
| Advanced Clinical Research Pharma | Miami, Florida |
