Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00412828 · ClinicalTrials.gov registry record · Phase 1

A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

A Phase 1 study of Unresectable Stage III or Stage IV Melanoma, sponsored by CuraGen Corporation.

Completed
Registry status
Phase 1
Development phase
117
Enrollment target
4
Study locations

NCT00412828 is a Phase 1 study of Unresectable Stage III or Stage IV Melanoma that has completed, run by CuraGen Corporation. The registered enrollment target is 117 participants. The trial reports 4 study locations across 4 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00412828, a Phase 1 study of Unresectable Stage III or Stage IV Melanoma, has completed, sponsored by CuraGen Corporation.

COMPLETED
Registry status
Phase 1
Development phase
117 participants
Enrollment target
4
Study locations

Study Summary

This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.

Interventions

  • DRUG CR011-vcMMAE

Study Locations (4)

California

  • Angeles Clinic and Research Institute - Santa Monica

Connecticut

  • Yale University - New Haven

New York

  • New York University Medical Center - New York

Texas

  • M.D. Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2006-06
Est. Completion 2011-05
Phase Phase 1

Sponsor

CuraGen Corporation

4 total trials

What the Registry Record Tells You About NCT00412828

The ClinicalTrials.gov registry entry for NCT00412828 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CuraGen Corporation, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Unresectable Stage III or Stage IV Melanoma appearing as the primary indexed condition, and to 1 intervention - of which CR011-vcMMAE is the first listed.

NCT00412828 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Connecticut, New York.

Frequently Asked Questions

What is clinical trial NCT00412828 about?

NCT00412828 is a clinical study titled "A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma". This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalatin...

What is the current status of trial NCT00412828?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2006-06. Estimated completion is 2011-05.

What conditions does trial NCT00412828 study?

This clinical trial studies the following conditions: Unresectable Stage III or Stage IV Melanoma.

What interventions are being tested in trial NCT00412828?

The interventions under investigation include: CR011-vcMMAE (DRUG).

Who is sponsoring clinical trial NCT00412828?

This trial is sponsored by CuraGen Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00412828 being conducted?

This trial has 4 study locations across California, Connecticut, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.