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NCT00931008 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate SID 530 Compared to Taxotere
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by SK Chemicals Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
- 4
- Study locations
NCT00931008: Completed Phase 3 study of Non-Small Cell Lung Cancer, sponsored by SK Chemicals Co..
NCT00931008 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by SK Chemicals Co.. The registered enrollment target is 42 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00931008, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by SK Chemicals Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
- 4
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG SID530, Taxotere
Study Locations (4)
Florida
- Advanced Clinical Research Pharma - Miami
Ohio
- Gabrail Cancer Center - Canton
Ch. Venkatka Krishnayya
- City Cancer Hospital - Vijayawada AndhraPradesh
Chennai, Tamilnadu
- Kamakshi Memorial Hospital - No-1, Radial Road, Pallikarani
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
What the finished NCT00931008 record still lists
NCT00931008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which SID530, Taxotere is the first listed.
NCT00931008 reports a single indexed study location in Florida, Ohio, Ch. Venkatka Krishnayya.
Frequently Asked Questions
What is clinical trial NCT00931008 about?
NCT00931008 is a clinical study titled "Study to Evaluate SID 530 Compared to Taxotere". 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 ...
What is the current status of trial NCT00931008?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2009-10. Estimated completion is 2011-01.
What conditions does trial NCT00931008 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT00931008?
The interventions under investigation include: SID530, Taxotere (DRUG).
Who is sponsoring clinical trial NCT00931008?
This trial is sponsored by SK Chemicals Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00931008 being conducted?
This trial has 4 study locations across Florida, Ohio, Ch. Venkatka Krishnayya, Chennai, Tamilnadu. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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42 352nd of 454 higher than 100 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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