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NCT01653028 · ClinicalTrials.gov registry record · Phase 2
Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
A Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Myxofibrosarcoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT01653028: Completed Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Myxofibrosarcoma, sponsored by National Cancer Institute (NCI).
NCT01653028 is a Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Myxofibrosarcoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 72 participants, below the 82-participant average among 11 other Recurrent Adult Soft Tissue Sarcoma trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01653028, a Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Myxofibrosarcoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients wit
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Alisertib
Study Locations (20)
Colorado
- The Medical Center of Aurora - Aurora
- Boulder Community Hospital - Boulder
- Rocky Mountain Cancer Centers-Boulder - Boulder
- Penrose-Saint Francis Healthcare - Colorado Springs
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs
- Porter Adventist Hospital - Denver
- Colorado Blood Cancer Institute - Denver
- Presbyterian - Saint Lukes Medical Center - Health One - Denver
- Rocky Mountain Cancer Centers-Midtown - Denver
- SCL Health Saint Joseph Hospital - Denver
- Rocky Mountain Cancer Centers-Rose - Denver
- Rose Medical Center - Denver
- Colorado Cancer Research Program NCORP - Denver
- Mercy Medical Center - Durango
- Comprehensive Cancer Care and Research Institute of Colorado LLC - Englewood
- Swedish Medical Center - Englewood
- Poudre Valley Hospital - Fort Collins
- Mountain Blue Cancer Care Center - Golden
- North Colorado Medical Center - Greeley
Arizona
- Mayo Clinic in Arizona - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2012-08-22 |
| Phase | Phase 2 |
What the finished NCT01653028 record still lists
NCT01653028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 82-participant average among 11 other Recurrent Adult Soft Tissue Sarcoma trials with a reported enrollment target (12% lower).
The record links to 8 conditions, with Recurrent Adult Soft Tissue Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01653028 names 20 study sites across 2 states, led by Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT01653028 about?
NCT01653028 is a clinical study titled "Alisertib in Treating Patients With Advanced or Metastatic Sarcoma". This phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells ...
What is the current status of trial NCT01653028?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2012-08-22.
What conditions does trial NCT01653028 study?
This clinical trial studies the following conditions: Recurrent Adult Soft Tissue Sarcoma, Myxofibrosarcoma, Recurrent Liposarcoma, Recurrent Undifferentiated Pleomorphic Sarcoma, Recurrent Malignant Peripheral Nerve Sheath Tumor.
What interventions are being tested in trial NCT01653028?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Alisertib (DRUG).
Who is sponsoring clinical trial NCT01653028?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01653028 being conducted?
This trial has 20 study locations across Arizona, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Adult Soft Tissue Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01653028's enrollment target sits among peer trials
72 6th of 11 higher than 6 of 11 other Recurrent Adult Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Adult Soft Tissue Sarcoma 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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