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NCT02719691 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT02719691: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT02719691 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02719691, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
This is a phase Ib study designed to evaluate the safety and toxicity of the combination of Alisertib and MLN0128 in patients with advanced solid tumors with an expansion cohort in patients with previously treated metastatic TNBC.
Primary Outcome
The maximum tolerated dose (MTD) will be defined as the highest dose level evaluated in which 0 or 1 patient out of 6 patients experiences dose limiting toxicity (DLT) in the combination of MLN0128 and Alisertib. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
Interventions
- DRUG Alisertib
- DRUG MLN0128
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2016-05-13 |
| Est. Completion | 2020-03-18 |
| Phase | Phase 1 |
What the finished NCT02719691 record still lists
NCT02719691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Alisertib is the first listed.
NCT02719691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02719691 about?
NCT02719691 is a clinical study titled "Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer". This is a phase Ib study designed to evaluate the safety and toxicity of the combination of Alisertib and MLN0128 in patients with advanced solid tumors with an expansion cohort in patients with previously treated metastatic TNBC.
What is the current status of trial NCT02719691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2016-05-13. Estimated completion is 2020-03-18.
What interventions are being tested in trial NCT02719691?
The interventions under investigation include: Alisertib (DRUG), MLN0128 (DRUG).
Who is sponsoring clinical trial NCT02719691?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02719691's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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