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NCT01799278 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01799278: Completed Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT01799278 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01799278, a Phase 2 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will evaluate the response rate of MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer (NEPC). MLN8237 is an orally administered Aurora kinase A inhibitor that has demonstrated broad antitumor activity in vitro and in vivo. In preclinical models, aurora kinase inhibition resulted in dramatic and preferential anti-tumor activity in NEPC with suppression of neuroendocrine marker expression.
Primary Outcome
Evaluated per RECIST 1.1 guidelines: Complete response (CR) is defined as complete disappearance of all measurable and evaluable lesions by physical examination or imaging studies and normalization of PSA with no appearance of new lesions for \> 1 month. Partial response (PR) is defined as a 30% 56 or greater reduction in the sum longest unidimensional diameter of all measurable lesions. There may be no new lesions. Stable Disease (SD) is characterized by patients who do not meet the criteria of
Interventions
- DRUG MLN8237
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-02 |
| Est. Completion | 2017-08 |
| Phase | Phase 2 |
What the finished NCT01799278 record still lists
NCT01799278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which MLN8237 is the first listed.
NCT01799278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01799278 about?
NCT01799278 is a clinical study titled "A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer". This study will evaluate the response rate of MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer (NEPC). MLN8237 is an orally administered Aurora kinase A inhibitor that has demonstrated broad antitumor activity in vitro and in vivo. I...
What is the current status of trial NCT01799278?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2013-02. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01799278?
The interventions under investigation include: MLN8237 (DRUG).
Who is sponsoring clinical trial NCT01799278?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01799278's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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