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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2007-07 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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