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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00356460 record still lists

NCT00356460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower).

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 lists 6 locations in 4 states (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.

Similar trials for Melanoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00356460's enrollment target sits among peer trials

29 205th of 266 higher than 61 of 266 other Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00356460, the US trial registry maintained by the National Library of Medicine. NCT00356460 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.