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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). 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 |
Why NCT00522834 stopped before completion
NCT00522834 is an interventional study that assigns participants to a tested intervention. The registered 630 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT00522834 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00522834's enrollment target sits among peer trials
630 581st of 2000 higher than 1,417 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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