A clinical trial to compare SID530 to Docetaxel by studying how body handles each drug and how safe each drug is in patients with non-small cell lung cancer or breast cancer
- Registration Number
- CTRI/2010/091/000382
- Lead Sponsor
- SK Chemicals, 948-1, Daechi-2dong, Gangnam-gu, Seoul, 135-847, Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 42
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to test the bioequivalence of SID530 to TaxotereTimepoint: Visit 2 and Visit 7
- Secondary Outcome Measures
Name Time Method to evaluate the safety and tolerbility of SID530Timepoint: during the entire period after dosing