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NCT00522834 · ClinicalTrials.gov registry record · Phase 3
Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
A Phase 3 study, sponsored by Synta Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 630
- Enrollment target
NCT00522834: Clinical Trial Phase 3 study, sponsored by Synta Pharmaceuticals.
NCT00522834 is a Phase 3 study that was terminated before completion, run by Synta Pharmaceuticals. The registered enrollment target is 630 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00522834, a Phase 3 study, was terminated before completion, sponsored by Synta Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 630 participants
- Enrollment target
Study Summary
"Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals. Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone. One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "
Interventions
- DRUG Paclitaxel
- DRUG Elesclomol (STA-4783)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00522834
The ClinicalTrials.gov registry entry for NCT00522834 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Synta Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT00522834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00522834 about?
NCT00522834 is a clinical study titled "Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma". "Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses,...
What is the current status of trial NCT00522834?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 630 participants. The study started on 2007-08. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00522834?
The interventions under investigation include: Paclitaxel (DRUG), Elesclomol (STA-4783) (DRUG).
Who is sponsoring clinical trial NCT00522834?
This trial is sponsored by Synta Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
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