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NCT00602576 · ClinicalTrials.gov registry record · Phase 2
Temozolomide and Sorafenib in Treating Patients With Metastatic or Unresectable Melanoma
A Phase 2 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
NCT00602576: Completed Phase 2 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT00602576 is a Phase 2 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602576, a Phase 2 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sorafenib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different schedules of temozolomide when given together with sorafenib to compare how well they work in treating patients with metastatic or unresectable melanoma.
Primary Outcome
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Interventions
- DRUG temozolomide
- DRUG sorafenib tosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2005-01-01 |
| Est. Completion | 2009-07-26 |
| Phase | Phase 2 |
What the finished NCT00602576 record still lists
NCT00602576 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which temozolomide is the first listed.
NCT00602576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00602576 about?
NCT00602576 is a clinical study titled "Temozolomide and Sorafenib in Treating Patients With Metastatic or Unresectable Melanoma". RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking bl...
What is the current status of trial NCT00602576?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2005-01-01. Estimated completion is 2009-07-26.
What interventions are being tested in trial NCT00602576?
The interventions under investigation include: temozolomide (DRUG), sorafenib tosylate (DRUG).
Who is sponsoring clinical trial NCT00602576?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00602576's enrollment target sits among peer trials
169 403rd of 2000 higher than 1,598 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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