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NCT01614795 · ClinicalTrials.gov registry record · Phase 2
Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01614795: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01614795 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01614795, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
This phase II trial studies how well cixutumumab and temsirolimus work in treating patients with recurrent or refractory sarcoma. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.
Primary Outcome
Per Response evaluation criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR)= CR+PR. The combination of sufficient activity is considered if the true response rate is 35% or greater.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Temsirolimus
- BIOLOGICAL Cixutumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2012-06-18 |
| Est. Completion | 2014-04-01 |
| Phase | Phase 2 |
What the finished NCT01614795 record still lists
NCT01614795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01614795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01614795 about?
NCT01614795 is a clinical study titled "Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma". This phase II trial studies how well cixutumumab and temsirolimus work in treating patients with recurrent or refractory sarcoma. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an...
What is the current status of trial NCT01614795?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2012-06-18. Estimated completion is 2014-04-01.
What interventions are being tested in trial NCT01614795?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temsirolimus (DRUG), Cixutumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01614795?
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 NCT01614795's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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