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

NCT00518895 · ClinicalTrials.gov registry record · Phase 3

Trial of Dacarbazine With or Without Genasense in Advanced Melanoma

A Phase 3 study, sponsored by Genta Incorporated.

Completed
Registry status
Phase 3
Development phase
300
Enrollment target

NCT00518895 is a Phase 3 study that has completed, run by Genta Incorporated. The registered enrollment target is 300 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00518895, a Phase 3 study, has completed, sponsored by Genta Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
300 participants
Enrollment target

Study Summary

This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.

Interventions

  • DRUG dacarbazine plus Genasense
  • DRUG dacarbazine plus placebo

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2007-07
Est. Completion 2011-05
Phase Phase 3

Sponsor

Genta Incorporated

12 total trials

What the Registry Record Tells You About NCT00518895

The ClinicalTrials.gov registry entry for NCT00518895 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genta Incorporated, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which dacarbazine plus Genasense is the first listed.

NCT00518895 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00518895 about?

NCT00518895 is a clinical study titled "Trial of Dacarbazine With or Without Genasense in Advanced Melanoma". This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a bioma...

What is the current status of trial NCT00518895?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2007-07. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00518895?

The interventions under investigation include: dacarbazine plus Genasense (DRUG), dacarbazine plus placebo (DRUG).

Who is sponsoring clinical trial NCT00518895?

This trial is sponsored by Genta Incorporated, which has 12 total clinical trials registered on ClinicalTrials.gov.

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.