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NCT01143402 · ClinicalTrials.gov registry record · Phase 2
Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT01143402: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01143402 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01143402, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
This randomized phase II trial studies temozolomide to see how well it works compared to selumetinib in treating patients with melanoma of the eye that has spread to other places in the body. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective than selumetinib in treating melanoma of the eye.
Primary Outcome
The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Temozolomide
- DRUG Dacarbazine
- DRUG Selumetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2010-06 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT01143402 record still lists
NCT01143402 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01143402 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01143402 about?
NCT01143402 is a clinical study titled "Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye". This randomized phase II trial studies temozolomide to see how well it works compared to selumetinib in treating patients with melanoma of the eye that has spread to other places in the body. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, ...
What is the current status of trial NCT01143402?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2010-06. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01143402?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Dacarbazine (DRUG), Selumetinib (DRUG).
Who is sponsoring clinical trial NCT01143402?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01143402's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 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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