Study to Evaluate SID 530 Compared to Taxotere
Completed · Phase 3
Conditions studied: Non-Small Cell Lung Cancer
In brief
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 SID530 to Taxotere. It will be conducted in study participants with locally advanced or metastatic NSCLC who have failed platinum therapy and also in participants with locally advanced or metastatic breast cancer who have failed at least one line of chemotherapy. Eligible study participants must be planning to have at least two consecutive 21-day cycles with 75 mg/m2 docetaxel monotherapy. The duration of study participation will be approximately 7 weeks. The study has three study phases: Screening (\<=1 week), Cycle 1 (21 days), and Cycle 2 (21 days).
Key facts
- Study ID
- NCT00931008
- Run by
- SK Chemicals Co., Ltd.
- People needed
- 42
- Starts
- 2009-10-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Advanced Clinical Research Pharma — Miami, Florida, United States
- Gabrail Cancer Center — Canton, Ohio, United States
- City Cancer Hospital — Vijayawada AndhraPradesh, Ch. Venkatka Krishnayya, India
- Kamakshi Memorial Hospital — No-1, Radial Road, Pallikarani, Chennai, Tamilnadu, India
Full record on ClinicalTrials.gov
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