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NCT01166126 · ClinicalTrials.gov registry record · Phase 2
Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT01166126: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01166126 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01166126, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to find out how often two investigational drugs that are given together will shrink the patient's tumor and how well they will prolong the time it takes their tumor to grow. The investigators also wish to find out how they affect certain substances in the patient's tumor and in their blood important for tumor growth. The combination of these drugs is experimental, and has not been proven to help treat melanoma
Primary Outcome
Anti-tumor response (CR+PR) was defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Interventions
- OTHER laboratory biomarker analysis
- DRUG selumetinib
- DRUG temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
Why NCT01166126 stopped before completion
NCT01166126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01166126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01166126 about?
NCT01166126 is a clinical study titled "Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV". The purpose of this study is to find out how often two investigational drugs that are given together will shrink the patient's tumor and how well they will prolong the time it takes their tumor to grow. The investigators also wish to find out how they affect certain substances in the patient's tumor...
What is the current status of trial NCT01166126?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2010-10. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01166126?
The interventions under investigation include: laboratory biomarker analysis (OTHER), selumetinib (DRUG), temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01166126?
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 NCT01166126's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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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