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Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma
NCT00356460 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of GC1008, a human anti-transforming growth factor-beta (TGFβ) monoclonal antibody in previously treated patients with locally advanced or metastatic renal cell carcinoma or malignant melanoma.
Conditions Studied
Interventions
- BIOLOGICAL GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody
Study Locations (6)
Massachusetts
- Dana Farber/Harvard Cancer Center, Dana Farber Cancer Institute — Boston
- Beth Israel Deaconess Medical Center — Boston
- Massachusetts General Hospital — Cambridge
Maryland
- National Cancer Institute (NCI) — Bethesda
New Jersey
- Cancer Institute of New Jersey — New Brunswick
Ohio
- Ohio State University — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00356460
The ClinicalTrials.gov registry entry for NCT00356460 describes a study currently listed as completed. It is categorized as Phase 1, 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. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 2 conditions, with Melanoma appearing as the primary indexed condition, and to 1 intervention — of which GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody 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: NCT00356460 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Massachusetts, Maryland, New Jersey. 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 NCT00356460 about?
NCT00356460 is a clinical study titled "Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma". The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of GC1008, a human anti-transforming growth factor-beta (TGFβ) monoclonal antibody in previously treated patients with locally advanced or metastatic renal cell carcinoma or malignant melanoma.
What is the current status of trial NCT00356460?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2006-09. Estimated completion is 2009-05.
What conditions does trial NCT00356460 study?
This clinical trial studies the following conditions: Melanoma, Carcinoma, Renal Cell. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00356460?
The interventions under investigation include: GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00356460?
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 NCT00356460 being conducted?
This trial has 6 study locations across Maryland, Massachusetts, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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