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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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 4 states.

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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

Non-Small Cell Lung Cancer

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

FieldValue
Enrollment Target 42 participants
Start Date 2009-10
Est. Completion 2011-01
Phase Phase 3

Sponsor

SK Chemicals Co.

1 total trials

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What the Registry Record Tells You About NCT00931008

The ClinicalTrials.gov registry entry for NCT00931008 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The listed sponsor is SK Chemicals Co., which has 1 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.