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Study of ILX651 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
NCT00078455 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase II, non-randomized, open label study of ILX651 in patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate. The secondary objectives are to determine the progression free survival, duration of response, time to tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic profile.
Conditions Studied
Interventions
- DRUG ILX651
Study Locations (10)
Texas
- US Oncology / Texas Cancer Center — Dallas
- Joe Arrington Cancer Center — Lubbock
- US Oncology / Tyler Cancer Center — Tyler
Arizona
- US Oncology/ Arizona Clinical Research Center — Tucson
California
- Cancer Institute Medical Group — Santa Monica
Colorado
- Anshutz Cancer Pavillion — Aurora
Florida
- US Oncology / Ocala Oncology — Ocala
Indiana
- US Oncology / Central Indiana Cancer Centers — Indianapolis
Louisiana
- Hematology and Oncology Specialists — New Orleans
Tennessee
- Sarah Cannon Cancer Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Start Date | 2003-12 |
| Est. Completion | 2005-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078455
The ClinicalTrials.gov registry entry for NCT00078455 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 1 intervention — of which ILX651 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00078455 reports 10 study locations spanning 8 distinct geographic areas — top geographies include Texas, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00078455 about?
NCT00078455 is a clinical study titled "Study of ILX651 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma". This is a Phase II, non-randomized, open label study of ILX651 in patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered int...
What is the current status of trial NCT00078455?
This trial is currently completed. It is a Phase 2 study. The study started on 2003-12. Estimated completion is 2005-08.
What conditions does trial NCT00078455 study?
This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00078455?
The interventions under investigation include: ILX651 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00078455?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00078455 being conducted?
This trial has 10 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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