Status:
COMPLETED
Study to Evaluate SID 530 Compared to Taxotere
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, blinded, two-period, two-sequence, crossover study, with a minimum 3-week washout period between treatments.The study is designed to evaluate the bioequivalence of ...
Detailed Description
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 D...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00931008
Start Date
October 1 2009
End Date
January 1 2011
Last Update
January 24 2013
Active Locations (4)
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1
Advanced Clinical Research Pharma
Miami, Florida, United States
2
Gabrail Cancer Center
Canton, Ohio, United States
3
City Cancer Hospital
Vijayawada AndhraPradesh, Ch. Venkatka Krishnayya, India
4
Kamakshi Memorial Hospital
No-1, Radial Road, Pallikarani, Chennai, Tamilnadu, India