NCT00931008

Study to Evaluate SID 530 Compared to Taxotere

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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 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 Study participants who are prematurely withdrawn from the study will be requested to complete the assessments conducted at the Final Visit.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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SID530, Taxotere	75mg/m2

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-07-02
• Last updated: 2013-01-24

Locations

4 sites across 2 countries: United States, India