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NCT00356460 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma

A Phase 1 study of Melanoma and Carcinoma, Renal Cell, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target
6
Study locations

NCT00356460 is a Phase 1 study of Melanoma and Carcinoma, Renal Cell that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 29 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 4 states.

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The verdict

NCT00356460, a Phase 1 study of Melanoma and Carcinoma, Renal Cell, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target
6
Study locations

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.

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

FieldValue
Enrollment Target 29 participants
Start Date 2006-09
Est. Completion 2009-05
Phase Phase 1

Sponsor

Genzyme, a Sanofi Company

196 total trials

What the Registry Record Tells You About NCT00356460

The ClinicalTrials.gov registry entry for NCT00356460 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

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.

NCT00356460 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, Maryland, New Jersey.

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.

What interventions are being tested in trial NCT00356460?

The interventions under investigation include: GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody (BIOLOGICAL).

Who is sponsoring clinical trial NCT00356460?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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