Study to Evaluate SID 530 Compared to Taxotere
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT00931008. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00931008
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2009 (Type not available)
- Primary completion
- Jan 2011 (Actual)
- Completion
- Jan 2011 (Actual)
- Last update posted
- Jan 24, 2013
2009 – 2011
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Clinical Research Pharma | Miami | Florida | — | — |
| Gabrail Cancer Center | Canton | Ohio | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00931008, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 24, 2013 · Synced Nov 14, 2026
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