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NCT02293005 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT02293005: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02293005 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02293005, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
Objectives: Objectives The primary objective of this study is to: To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with alisertib The secondary objectives of this study are to: To assess the response rate (confirmed and unconfirmed complete + partial responses) To assess the progression-free survival. To assess overall survival. To evaluate the side effects and toxicities associated with this treatment regimen. To collect archival tissue, blood, pleural effusion fluid and plasma for correlative studies. Exploratory Objectives: To collect archival or new tissue, blood and pleural effusion fluid for correlative studies. Tissue biomarkers to be evaluated include aurora kinase pathway and c-myc gene amplification. Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.
Primary Outcome
Patients who are free of disease progression at 4 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Interventions
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-05-20 |
| Est. Completion | 2021-07-06 |
| Phase | Phase 2 |
What the finished NCT02293005 record still lists
NCT02293005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Alisertib is the first listed.
NCT02293005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02293005 about?
NCT02293005 is a clinical study titled "Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma". Objectives: Objectives The primary objective of this study is to: To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with alisertib The secondary objectives of this study are to: To assess the response rate (confir...
What is the current status of trial NCT02293005?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2015-05-20. Estimated completion is 2021-07-06.
What interventions are being tested in trial NCT02293005?
The interventions under investigation include: Alisertib (DRUG).
Who is sponsoring clinical trial NCT02293005?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02293005's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 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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