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NCT00678769 · ClinicalTrials.gov registry record · Phase 1
Cixutumumab and Temsirolimus in Treating Patients With Locally Advanced or Metastatic Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT00678769: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00678769 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00678769, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of cixutumumab and temsirolimus in treating patients with locally advanced or metastatic cancer. Monoclonal antibodies, such as cixutumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may kill more cancer cells.
Primary Outcome
Other markers include: insulin-like growth factor 1 receptor (IGF-1R), phosphorylated (p)IGF-1R, insulin receptor substrate-1 (IRS-1), phosphatase and tensin homolog gene (PTEN), vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, and cluster of differentiation (CD)31. Generalized Estimating Equations model will be used to model the correlated IHC score between treatment arms.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Temsirolimus
- OTHER Pharmacological Study
- DRUG Cixutumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2008-05 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
What the finished NCT00678769 record still lists
NCT00678769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00678769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00678769 about?
NCT00678769 is a clinical study titled "Cixutumumab and Temsirolimus in Treating Patients With Locally Advanced or Metastatic Cancer". This phase I trial studies the side effects and best dose of cixutumumab and temsirolimus in treating patients with locally advanced or metastatic cancer. Monoclonal antibodies, such as cixutumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread....
What is the current status of trial NCT00678769?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2008-05. Estimated completion is 2015-10.
What interventions are being tested in trial NCT00678769?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temsirolimus (DRUG), Pharmacological Study (OTHER), Cixutumumab (DRUG).
Who is sponsoring clinical trial NCT00678769?
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 NCT00678769's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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