Study to Evaluate SID 530 Compared to Taxotere

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 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).

Timeline

Start

2009-10

Primary completion

2011-01

Completion

2011-01

Drugs

Indications