Study to Evaluate SID 530 Compared to Taxotere

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.
• Treatments: Docetaxel

Criteria

Inclusion Criteria: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 Criteria: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